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Meisel to Speak at Institute's First Gardere & Wynne Health Law Lecture

Alan Meisel of the University of Pittsburgh School of Law will deliver the first annual Gardere & Wynne Health Law Lecture on February 24, 1998. The topic of Professor Meisel's presentation will be "Managed Care and Decision-Making at the End of Life." An article by Professor Meisel on the same topic will be included in the Health Law Symposium issue of the Houston Law Review, which will be published in the spring of 1999. The title of the symposium issue will be "Managed Care and the Physician-Patient Relationship."

The lecture is underwritten by the law firm of Gardere & Wynne, L.L.P., which has offices in Dallas, Houston, Tulsa, and Mexico City. Gardere & Wynne merged with Houston's Sewell & Riggs in 1995. The establishing of the annual health law lecture coincides with the expansion of the firm's health care practice section. Sam Crocker, long time member of the Institute's Advisory Board and Vice President for Legal Affairs at Baylor College of Medicine, will be joining the firm in January.

Professor Meisel is the Dickie, McCamey & Chilcote Professor of Bioethics and Professor of Law and Psychiatry at the University of Pittsburgh School of Law. He also serves as Director of the Center for Medical Ethics at the University of Pittsburgh. He graduated from Yale College in 1968 and Yale Law School in 1972. Professor Meisel is a prolific author. Two of his best known works are The Right to Die (2d ed. 1996) and Informed Consent: Legal Theory and Clinical Practice (with Appelbaum and Lidz) (1987).

The presentation will be open to the public. For details, e-mail crupf@uh.edu.

Institute Receives Grant to Study Managed Care and People with Disabilities

The Health Law & Policy Institute has received a $50,000 grant from the National Institute on Disability and Rehabilitation Research of the U.S. Department of Education. The Health Law & Policy Institute will be working with The Institute for Rehabilitation and Research (TIRR) and will conduct legal research as part of a TIRR study to identify the barriers to accessing appropriate health care services faced by persons with disabilities enrolled in managed care. The Health Law & Policy Institute will begin work on this three-year study in June 1998.

The Institute, along with TIRR researchers, will: (1) prepare a description of protections currently afforded persons with disabilities, including gaps and weaknesses in current protective legislation and regulations; (2) compile and evaluate the health-related complaints reported to protection and advocacy (P&A) agencies and the characteristics of individuals who file these complaints; (3) research and review federal and state case law relative to persons with disabilities and treatment rendered in managed care organizations; (4) formulate policy recommendations designed to strengthen protections afforded persons with disabilities enrolled in managed care; (5) disseminate information from the study to policy makers, legal scholars, P&A personnel, and consumer groups.

Institute to Host National Health Law Teachers Conference

The National Health Law Teachers Conference of the American Society of Law, Medicine & Ethics will be held June 4-6, 1998 in Houston, Texas. The conference, hosted by the Health Law & Policy Institute, will feature a wide range of presentations and discussions on current issues in health law, health policy, and bioethics. For more information, please e-mail us at crupf@uh.edu.

Barriers to Health Care Access for People with Disabilities

Laura F. Rothstein
Law Foundation Professor of Law

This presentation was given at the Elizabeth Rockwell Discover UH Lecture Series on November 18, 1997. Elizabeth D. Rockwell, Executive Director, Private Client Division of CIBC Oppenheimer Corp., sponsors the Discover UH Lecture Series at the University of Houston. The lecturers are selected for monthly presentations to the Houston community. Mrs. Rockwell, who was a student at the University of Houston, is a nationally recognized expert in estate, retirement, investment, and tax planning, and a strong supporter of the University of Houston. In addition to sponsoring the Discover UH Lecture Series, she serves as President of the UH College of Business Administration Foundation Board, as a member of the CBA Dean's Advisory Board, and as an Executive Professor of the Business College. She is also a Trustee of the University of Houston System's Foundation.

Professor Laura F. Rothstein, Dean Stephen Zamora, and Elizabeth D. Rockwell

Imagine that you have a disability, such as a mobility impairment, deafness, mental retardation, or diabetes. Like everyone else, you would need and want routine physical exams and regular dental checkups In addition to needing routine care, your disability may require you to make frequent visits to a variety of health care specialists. What barriers would you face because of your disability in gaining access to health care?

Obviously, the first barrier is having health insurance to pay for health care services. Because most health insurance is tied to the workplace, individuals with disabilities face two problems. To begin with, they must be able to obtain and keep a job. Individuals with disabilities are underemployed and often face discrimination. Employers are concerned about the high cost of health care for individuals with disabilities. They have a disincentive in many cases to hire such individuals, even though it violates disability discrimination laws to do so.

Next, some individuals with disabilities, because of the limitations of their conditions, may not be able to work. Obtaining health care coverage through an individual health insurance policy is not a viable option for many individuals with disabilities. It is extremely expensive to purchase individual health insurance; the health insurance policy may not cover all types of treatments that an individual with a disability might need; or the policy may limit coverage for preexisting conditions. Even though the Americans with Disabilities Act permits excluding preexisting conditions and charging people with disabilities higher rates, these practices are now prohibited by the Kennedy-Kassebaum law (which was enacted as the Health Insurance Portability and Accountability Act) in 1996. The Kennedy-Kassebaum law prohibits disability-based discrimination in health insurance only with regard to employer-sponsored group health plans. And it is important to note that neither the ADA nor the Kennedy-Kassebaum bill require employers to provide health insurance in the first place.

Under capitated health care systems, individuals with chronic illnesses represent increased costs to the providers and therefore are not desirable enrollees. That's why you see Medicare HMOs recruiting new customers at senior athletic events, square dances, and other activities where good health is usually a prerequisite.

One could spend a great deal of time just focusing on the health insurance barrier, but for individuals with disabilities there are a number of other barriers which may not be as apparent. The Health Law & Policy Institute studied some of these barriers as part of its 1995 report to the Texas Legislature.

One of these nonfinancial barriers is the environment. While the Americans with Disabilities Act and other federal, state, and local laws have dramatically improved accessibility in places where health care providers are physically located, several environmental barriers remain in many cases. One environmental barrier is transportation. Again, while new laws have made for a more accessible transportation system, ask any individual who has tried to use the paratransit or regular Metro bus system about the barriers that still exist in terms of advance planning to reserve a pickup and drop off, and the wasted hours waiting for the paratransit vehicle or a regular bus with the necessary lift equipment to accommodate an individual in a wheelchair.

While significant improvement has been made in accessibility on the regular bus system, this is not a system that can be used by everyone -- either because their disabilities are too severe or because the bus stops are too distant from their home or destination point. For an individual with a disability who has chronic health care needs, and who does not have a car, the frequent visits to a physician's office can be a logistical nightmare, and because managed care organizations often require the individual to first visit a referring physician, transportation problems can prohibit access to health care.

As a side note, while the world in general is becoming more sensitive and accessible to individuals with disabilities-- as demonstrated by the fact that Mattel has created a new doll - "wheelchair Barbie" -- the sensitivity sometimes does not go far enough, as demonstrated by the fact that shortly after announcing the creation of "wheelchair Barbie," it was discovered that her wheelchair was too wide to fit through the door of Barbie houses sold by Mattel.

A second type of environmental barrier is the health care office equipment itself. While most health care providers today have facilities that enable an individual with a wheelchair to enter the building and office and patient care area, individuals with some impairments may have special needs that are not readily met. For example, an individual with severe arthritis or a wheelchair user may not be able to transfer to the fixed and specialized chair used for an eye or dental exam. A few providers, however, have been exemplary. The University of Houston School of Optometry provides an accessible chair that is a model for access.

The third type of barrier is simply discrimination based on prejudice, myths, and stereotypes. The public is most aware of this through the cases where health providers (particularly dentists) have refused to treat patients with disabilities, especially HIV. Other examples are health care providers refusing treatment to individuals who are mentally retarded or who have mental illness.

A variation on the plain old discrimination barrier is the barrier related to accommodations, such as auxiliary aids and services. For example, with patients who are deaf, it is important to ensure the communication necessary to make informed decisions and to understand treatment.

So, how well does current law address these issues and work to help remove these barriers? As I noted previously, the Americans with Disabilities Act (passed in 1990), has done a great deal to lower barriers. Its mandates affect both public and private health care providers as well as employers. It requires some removal of existing architectural and transportation barriers and provides design specifications to ensure that new construction and transportation systems are accessible at the outset.

The law has been the most successful in removing environmental barriers. Although individuals in wheelchairs still have to wait, mass transit is still substantially improved from the pre-ADA days.

The ADA has also provided a basis for challenging discriminatory practices, such as those that affect individuals with HIV. The litigation challenging discriminatory treatment and refusal to treat has resulted in successful attacks on such practices. Unfortunately, not everyone has the financial resources or the awareness of law to use legal challenges. In this area, more public education to reduce myths and stereotypes must be combined with the lawsuits to remove these barriers.

While environmental and attitudinal factors are important, access to health care remains an unresolved issue of national urgency. The United States is the only industrialized nation without a health care system guaranteeing universal access. And despite the hoopla associated with recent advances, we will soon reach the limits of possible incremental reforms.

What, if anything, will cause the mobilization of public support and political will that for over 50 years has been lacking to adopt comprehensive reform?

Perhaps the driving force to make this happen will be when a critical mass of aging, but pre-Medicare, baby boomers begin becoming disabled themselves and start being squeezed out of the health care system.

One of life's undeniable truths is that almost all of us will be disabled at some time. When we knock down barriers for people with disabilities, we are knocking down barriers for all of us.

Gattaca and Today's Genetic Secrets

Mark A. Rothstein
Hugh Roy and Lillie Cranz Cullen Distinguished Professor of Law

Professor Rothstein is the editor of Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era, published in December 1997 by Yale University Press.

While Vincent's efforts to keep his genetic secret make for a sci-fi thriller, millions of people today already are struggling to protect their genetic secrets. They are trying to keep third parties, such as employers and insurers, from gaining access to genetic information about their disease predispositions. If discovered, these people risk being doomed to join the 40 million other quintessentially American undesirables -- the uninsured.

Although there is widespread public support for preventing the inappropriate disclosure of genetic information, there are numerous practical problems. For one, it is virtually impossible to define "genetic information." Besides the results of DNA-based genetic tests, common diagnostic tests and family health histories are sources of genetic information. Moreover, new genetic discoveries have identified a genetic role in numerous common disorders, including many cancers, heart disease, diabetes, epilepsy, and osteoporosis.

The public's heightened concern about genetics is understandable. Genetic traits are transmitted from one generation to the next, and earlier in this century human genetic variation was used to justify eugenics and genocide. Nevertheless, from a scientific standpoint, today it is impossible to develop a meaningful distinction between genetic and nongenetic medical information. Even if this were possible to do, applying separate rules for genetic information would only increase the stigma of genetic disorders.

Some proposals seek to protect confidentiality by, among other things, prohibiting any disclosure of genetic information without written consent. While procedural limitations on unauthorized disclosure are helpful, the more difficult issue is preventing the authorized disclosure of genetic information. Individuals now are often compelled to release all of their medical records, which would include genetic information, as a condition of obtaining employment, insurance, or other opportunities.

Attempts to regulate the use of genetic information quickly become larger and more daunting tasks. For example, determining whether it is reasonable for health insurance companies to discriminate against individuals based on genetic factors that predict future illness is merely the first step. Next, one must consider whether it is reasonable for insurers to discriminate against individuals with genetic or other disorders after they become ill. Ultimately, the question is whether all individuals have a right of access to health care. Thus, new genetic discoveries may heighten current concerns, but "genetic" questions cannot be resolved independently. Fundamental public policies regarding numerous contentious issues are implicated by today's genetic secrets.

The age of Gattaca may lie in the future, but the challenging age of genetic secrets already is here.

Institute Hosts Health Officials from Vietnam and the Phillipines

In September, the Health Law & Policy Institute, in conjunction with the World Health Organization, hosted two fellows from the Ministry of Health in Vietnam and one from the Philippines. Dr. Tran Thu Thuy, Director, Department of Therapy, and Dr. Trinh Thi Le Tram, Deputy Director, Health Legislation Department, spent two weeks in Houston visiting various state health agencies, hospitals, and community organizations. They spent the following week in Austin meeting with additional state agencies, legislative committees, and local health departments.

Ms. Kathleen Del Rosario, Legislative Consultant with the Department of Health in the Philippines, had a similar schedule in both Houston and Austin.

The meetings were set up with health officials in order to furnish the fellows with information they could take back to their countries concerning the United States health care system.

Thank You

The Health Law & Policy Institute extends its thanks to Thompson & Knight for its generous support.

Focus on Our Graduates

Susan Feigin Harris (J.D. '88) recently left her position as the Vice President of the Legal and Administration Division of the Texas Medical Center, a position she had held since May 1994. She will join the Health Practice Group of the Houston office of Jenkens & Gilchrist, P.C., as Senior Attorney.

Colleen Faddick (J.D. '95) recently wrote an article entitled "Health Care Fraud and Abuse: New Weapons, New Penalties, New Fears for Providers Created by the Health Insurance Portability and Accountability Act of 1996 ("HIPAA")" that was published in Annals of Health Law, 1997.

John J. Fraser, Jr., M.D., J.D., M.P.H. (J.D. '96) has moved from the University of Texas-Houston Medical School to the Department of Emergency Medicine at the University of Texas Medical Branch at Galveston, where he is an Associate Professor. He has achieved status as a Diplomate of the American Board of Forensic Medicine. He presented a paper entitled "Chain of Custody: The Pediatric Sexual Abuse Forensic Examination" to the Health Law Forum at the 125th annual meeting of the American Public Health Association on November 11, 1997 in Indianapolis, Indiana.

Alumni, please let us know what you are doing so we may include it in future issues. You can e-mail us at crupf@uh.edu.

Publications. . .

Laura F. Rothstein

• Disabilities and the Law (2d ed.) (WestGroup 1997)
• Genetic Testing in Schools, chapter in Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (Yale University Press 1997)
• "Higher Education and Disabilities: Trends and Developments," 27 Stetson Law Review 1 (1997)
• "Higher Education and Disabilities: An Overview of 1995 Cases," 23 Journal of College and University Law 475 (1997)

• Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (Yale University Press 1997)

Mary Anne Bobinski

• Has been appointed to the Advisory Board of the Foundation for Genetic Medicine
• Has been appointed Associate Dean of Academic Affairs of the University of Houston Law Center as of January 1, 1998

• Will be advising the Texas Leadership Team on ethical, legal, and policy issues in connection with its guidance of the Family Violence Prevention Fund's National Health Initiative on Domestic Violence

• Has been selected as a judge of and planning committee member for the Health Care Team Clinical Competition of the University of Texas Health Science Center-Houston
• Served as a member of the planning committee for the Joint Annual Meeting of the Society for Bioethics Consultation, Society for Health & Human Values, and the American Association of Bioethics in Baltimore, Maryland, November 5-9, 1997
• Began conducting clinical ethics rounds at the University of Texas M.D. Anderson Cancer Center

• Served as Chair of the Planning Committee for the Joint Conference on Disabilities Issues held by the ABA, AALS, LSAC, and NCSBE November 13-15, 1997 in Washington, D.C.

• Has been appointed to a three-year term as member of the Social Issues Committee of the American Society of Human Genetics
• Has been appointed to the Editorial Board of the Journal of Biolaw & Business Recent

Mary Anne Bobinski

• "The ADA and HIV," Health Care AIDS Symposium, Albany Law School, Albany, New York, November 12, 1997
• "Legal, Ethical, and Policy Implications of HIV," Thomas Street Clinic, Houston, Texas, November 1997
• "Trends in Health Care," Houston Chapter of the National Association for Business Economics, Houston, Texas, December 18, 1997

• "The Americans with Disabilities Act-Titles II and III (Public Services and Public Accommodations)," Federal Judicial Center Workshop for First Circuit Judges, Providence, R.I., September 27, 1997
• "Affirmative Action," University of Iowa School of Law, October 4, 1997
• "Current Issues for Disabled Persons on College and University Campuses," University of Houston Administrators, October 10, 1997
• "Lessons from Disability Discrimination Law for the Affirmative Action Debate in Legal Education and the Legal Profession," American Council on Education National Conference, Miami, Florida, October 15, 1997
• "Employment and Disability Discrimination," Houston Bar Association, Labor and Employment Section, November 3, 1997
• "Barriers to Health Care Access and People with Disabilities," Elizabeth Rockwell Discover-UH Lecture Series, November 18, 1997 Mark A. Rothstein
• "Studying the Effects of Minnesota's Law Limiting Employer Access to Employee Medical Records," U.S. Department of Energy, Santa Fe, New Mexico, November 10, 1997
• "Legal and Ethical Issues Raised by Genetic Testing in Employment and Insurance," M.D. Anderson Cancer Center, November 14, 1997

• "Legal and Ethical Issues in Prescribing Opioid Analgesics," College of Nursing, University of Texas Health Science Center-Houston, Houston, Texas, October 21, 1997

"Update on Managed Care Legislation," Texas Cancer Council, Austin, Texas, November 13, 1997

Dr. Mary desVignes-Kendrick Receives APHA Prize

Institute Advisory Board member Dr. Mary desVignes-Kendrick was awarded the American Public Health Association's Milton and Ruth Roemer Prize for Creative Local Public Health Work at the Association's 125th Annual Meeting held on November 8, 1997 at its Affiliate Leadership meeting in Indianapolis, Indiana.

The prize recognizes a local health officer of a county, city, or other unit of local government who has been found to be responsible for outstanding creative and innovative health work. Dr. desVignes-Kendrick, a pediatrician and director of the City of Houston Department of Health and Human Services, has been instrumental in developing programs for underserved, at-risk populations.

University of Houston Team Wins Second Place in National Health Law Moot Court Competition

The University of Houston Law Center team of Marissa Weitzner and Craig Adams took second place in the National Health Law Moot Court Competition held November 8-9, 1997 at Southern Illinois University in Carbondale, Illinois. Thirty-two teams from twenty-four law schools participated in the tournament. Craig Adams was named Best Oralist in the competition.

Institute Assists with Interim Studies for the Legislature

The Health Law & Policy Institute will be assisting the House Public Health Committee, Senate Health and Human Services Committee, and the House State Affairs Committee of the Texas Legislature with research based on the interim charges of these committees. The Institute's research will include: a review of the Indigent Care Act and possible revisions; the impact of conversion of nonprofit hospitals to for-profit; the coverage of undocumented aliens under the Indigent Care Act; legal and ethical issues at the end of life; billing practices of Texas hospitals; and issues raised by new genetic discoveries.

In addition, as of June 1, 1998, the Institute will sponsor a full-time health law fellowship, which will involve working for the House Public Health Committee for one year. In January 1999, the Institute will sponsor at least two more fellows working at the Capitol during the legislative session.

Health Law Organization Honors Connie Wallace

Cheryl Erwin and Connie Wallace

The Health Law Organization of the University of Houston Law Center held an Alumni Recognition Breakfast on November 14, 1997. Cheryl Erwin, president of the HLO, presented an Alumni Recognition Award for outstanding service to the health law community to Connie Wallace, who received a J.D. from the Law Center in 1990. Ms. Wallace is the Director of Risk Management for The Methodist Health Care System, where she has worked for five years.

New Faculty and Classes for Spring Semester

New adjunct and visiting professors will be teaching in the 1998 Spring Semester, and one class is being offered for the first time at the University of Houston Law Center.

David C. Pate, J.D., M.D., and Robin Fretwell Wilson, J.D., will be teaching Regulation of Health Care Professionals. Dr. Pate is Senior Vice President of St. Luke's Episcopal Health System and Medical Director of St. Luke's Health Network. Ms. Wilson is an associate at Mayor, Day, Caldwell & Keeton LLP.

Judge Caroline E. Baker will be teaching Medical Malpractice. Judge Baker is the presiding judge of the 151st District Court of Harris County, Texas.

Ronald Turner, Visiting Associate Professor of Law at the Law Center, will be teaching Current Issues in the Law (HIV). Professor Turner is an Associate Professor of Law at the University of Alabama.

A new class on Health Legislation will be taught by Professor Laura F. Rothstein. It will include guest lectures by numerous current and former members of the state legislature, state agency officials, and other policy makers involved in legislation at the federal, state, and local levels.

Winslade Gives Tenneco Lecture

Professor William J. Winslade presented the Tenneco Lecture on "Assisted Suicide: Who Should Decide?" on October 30, 1997. Professor Winslade is a Distinguished Visiting Professor and Associate Director for Graduate Programs at the Health Law & Policy Institute and is the James Wade Rockwell Professor of Philosophy in Medicine at the University of Texas Medical Branch at Galveston.

Wing to Teach Intersession Course on Public Health Law

The Health Law & Policy Institute will offer a course on Public Health Law January 5-16, 1998. The course will be taught by Visiting Professor Kenneth R. Wing, a professor of law at Seattle University. Professor Wing also teaches health law at the School of Public Health and Community Medicine at the University of Washington.

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SPECIAL SECTION
Food and Drug Law

Introduction

Marcus L. Stevenson

Marcus Stevenson was Assistant Chief Counsel for Enforcement in the Office of Chief Counsel at the United States Food and Drug Administration before entering the Health Law LL.M. program at the University of Houston Law Center in the fall of 1997. He received a B.B.A. in 1992 from Texas A&M University and a J.D. in 1995 from Boston College.

As recently as October 1997, FDA was one of ten winners of the prestigious Innovations in American Government co-sponsored by the Ford Foundation and Harvard University's J.F.K. School of Government. Specifically, FDA was honored for improving the rate by which it approved new drugs for the market while maintaining the safety and effectiveness standards set forth in the FDCA. Evidence of FDA's responsiveness to both its critics and defenders can be seen in the way FDA continues to review the safety of approved drugs, such as dexfenfluramine and fenfluramine. Other examples of FDA's commitment to its charge include: (1) approving a narcotic lollipop, under the trade name Actiq, to control cancer pain; (2) warning the public that the allergy drug, Seldan, could cause a potentially fatal heart condition if used in combination with several new drugs; (3) improving the approval process and processing time for pre-market approval applications for medical devices; (4) requiring all medical devices containing latex to be labeled as such to caution users about possible allergic reactions; (5) targeting clinics that use unapproved lasers to treat nearsightedness and other eye conditions; (6) prosecuting oxygen manufacturers for failure to comply with current Good Manufacturing Practice requirements for drugs; (7) issuing final regulations for mammography facilities; and (8) initiating plans for a comprehensive regulatory framework for products derived from human cells and tissues.

The FDA Modernization Act of 1997 was signed into law by President Clinton on November 21, 1997. Its goal is to make new drugs and medical devices available to the public more quickly. It provides for hiring additional reviewers of drug applications, use of independent outside reviewers for device applications, and expanded access to experimental drugs for the seriously ill.

The following articles discussing food and drug law in this issue are critical to understanding the trends in this area of law. Specifically, the articles will address regulation of tissue and cell products, off-label uses of drugs, state regulation, and legislative reform. In addition, this issue will identify enforcement concerns faced by the Department of Agriculture and its desire to obtain expanded regulatory authority to shut down non-compliant meat packing facilities. There are obviously many other controversial and critical topics that could be discussed with respect to both FDA and the Department of Agriculture. These articles are designed to highlight some of the evolving legal complexities affecting United States food, drug, device, biologic, and cosmetic products.

Improving the Safety of America's Meat and Poultry: Why We Need the Food Safety Enforcement Enhancement Act

Dan Glickman
United States Secretary of Agriculture

As the United States adopts a new, state-of-the-art, science-based meat and poultry inspection system, the promise of a food safety revolution looms large on the horizon. But for this system to live up to its full potential, we must modernize the way government and the food industry ensure the safety of America's food.

Much has changed in the 90 years since our last food safety revolution. Today's meat and poultry plants are large operations that can quickly move millions of pounds of product into grocery stores and restaurants across the country. We now know that traditional sight-touch-and-smell inspections overlook the hidden dangers in our food -- bacterial pathogens like E. coli O157:H7 and salmonella -- that pose the greatest threat to human health.

This Administration is working on a number of fronts to strengthen food safety: international efforts to lift other countries' food safety standards; research into the root causes of contamination; a major consumer education campaign; expanded nationwide monitoring to more quickly control outbreaks of food-borne illness. In addition, we are asking Congress to approve the Food Safety Enforcement Enhancement Act of 1997.

This act will allow USDA to fine companies that fail to meet America's high food safety standards. It will also give USDA the authority to better protect consumers by allowing us to order recalls of unsafe meat or poultry, and require businesses to notify USDA when potentially contaminated meat or poultry may be in the marketplace. These tools are no substitute for aggressive inspections, but they will help guarantee safer food for America's consumers.

This legislation is critical to the new inspection system which we call Hazard Analysis and Critical Control Points. HACCP focuses on preventing contamination, instead of merely catching it after it occurs. But for this new approach to work, government must be able to enforce it.

Right now, when it comes to meat and poultry safety, government's primary power is what we call the 'atomic bomb' -- the power to withdraw inspectors, and effectively shut a plant down.

As industry strives to meet tougher inspection standards, government needs degrees of power to help ensure that companies pay attention to details -- from keeping good records to practicing each step in their required safety plans. The authority to assess civil penalties will give us that ability.

We also need to ensure that companies notify the government promptly when they suspect contaminated food has entered the marketplace. USDA uncovered a situation where a company notified a restaurant chain about potentially unsafe food 48 hours before they told us. As a result, the chain pulled the food two days before grocery stores and public health officials even had a chance to act.

Mandatory recalls are equally essential. They short circuit the rare bad actor who stalls when prompt action is necessary, and they ensure a rapid response throughout the commercial food chain -- quickly removing food from restaurants, warehouses, supermarkets and corner stores.

These authorities are nothing new. In fact, the Food Safety Enforcement Enhancement Act simply gives USDA the power that already exists to protect consumers from other unsafe products. When a car kills due to faulty manufacturing, or a plane engine fails revealing critical safety gaps, or a toy harms the children it was meant to please, government can act quickly to pull these dangerous products from the marketplace. It can also fine those who compromise our safety.

Government cannot use these same powers to protect you from unsafe food. In fact, in the case of civil fines, USDA has more authority to protect circus elephants than to protect consumers.

It is time to stop treating unsafe food differently from other threats to public health. The Food Safety Enforcement Enhancement Act will end this inequity, and give America's consumers even greater confidence that they have the safest possible food supply.

FDA Legislation Streamlines Drug Regulation

Alan F. Holmer
President
Pharmaceutical Research and Manufacturers of America

President Clinton recently signed into law constructive legislation that will help usher drug regulation into the 21st century. Here are the key provisions of the law:

• Reauthorization of the Prescription Drug User Fee Act of 1992, which has cut drug review times in half. Under the 1992 law, drug companies paid $327 million in user fees to the Food and Drug Administration over a five-year period. The funds were used to hire 600 additional reviewers, cutting average drug review times from 29.2 months in 1992 to 15.5 months in 1996. Under the renewed law, companies are expected to pay an additional $600 million over the next five years, which will further reduce review times.
• Consensus provisions that will streamline regulation and help cut total drug development time. The legislation codifies the discretion FDA already has to decide whether one or more large-scale clinical trials are needed to determine the effectiveness of a drug. It also makes common sense changes to the procedure companies must use to institute manufacturing changes. It will facilitate approvals of new indications, or uses, of already approved drugs. It will make "off-label" prescribing safer by allowing manufacturers to give physicians articles from reputable medical journals documenting such use. It will allow manufacturers to disseminate health care economic information about their drugs to managed care entities. It will streamline FDA processes and expedite decision-making. Together with the extension of the user fee law, these provisions could cut total drug development time - which now takes about 15 years - by an estimated 10 to 16 months. And the legislation will accomplish this without compromising safety. The same number of safety tests will be performed on the same number of patients.
• Provisions that will give added benefits to patients. In addition to helping patients by making safe and effective drugs available sooner, the legislation would also give seriously ill patients easier access to experimental medicines. It will put drugs for life-threatening illnesses on a faster track, and it will provide incentives to develop medicines for children.

FDA's Regulation of Cellular and Tissue-Based Products

Jill Warner
Regulatory Counsel to the Director
Center for Biologics Evaluation and Research
Food and Drug Administration

Of the myriad products that the Food and Drug Administration (FDA) regulates, few are as diverse within a class as tissues and cells derived from the body. The term "tissues" has been used to refer to materials such as skin, bone, and ocular tissue transplanted for replacement purposes, as well as to newer therapies developed from manipulated cells and tissues. The development of cellular and tissue-based therapies is a fast-growing area with potentially thousands of different applications.

FDA's regulation of this broad range of products has, in the past, been fragmented and sometimes confusing. In 1993, FDA promulgated limited interim (now final) requirements that donors of conventional human tissue used for replacement purposes be tested for HIV and hepatitis and screened for risk of infection. However, reproductive tissues such as semen and ova were not covered by this regulation.

Other products, such as highly manipulated cellular products known as somatic cell therapies, have been comprehensively regulated as "biologics." FDA has long regulated biologics, a term comprising viruses, therapeutic sera, toxins, antitoxins, vaccines, blood, blood components and derivatives, allergenic products, and analogous products, under the authority of section 351 et seq. of the Public Health Service Act (PHS Act). Biologics are also "drugs" or "devices" within the meaning of section 201 of the Food, Drug, and Cosmetic Act (FDCA), and therefore are subject to additional requirements and controls specified in the FDCA. Among other provisions, the PHS Act requires that a biological product manufacturer apply for and obtain a license from FDA before the product may be marketed. Such premarket approval must be based on a showing that the biological product is safe, pure, and potent.

The agency realized that cellular and tissue-based products and their potential applications are too varied for a single set of regulatory requirements to be appropriate for all. Accordingly, during late 1996 and early 1997, a dedicated group of scientists and policy experts within FDA worked intensively to develop an approach to regulation that would be rational and risk-driven. When we examined our past regulatory efforts, we found that we had been evaluating the degree of risk and level of regulation product by product, in a linear hierarchy. In fact, cellular and tissue-based products each have (or lack) a number of characteristics which in themselves pose different degrees of public health concern. The degree of regulation should be appropriately scaled to the type of concern and degree of risk posed by each product characteristic.

FDA's Proposed Approach to the Regulation of Cellular and Tissue-Based Products, published in February 1997 in tandem with the Vice President's National Performance Review -- "Reinventing the Regulation of Cells and Tissues," establishes a comprehensive framework for regulation of these products that will treat like products alike but that will establish regulatory distinctions where there are differences among product characteristics. FDA will be implementing the Proposed Approach by publishing a series of rulemakings. In order to establish this sliding scale of regulation, the agency will utilize authorities in the FDCA, section 351 et seq. of the PHS Act, and section 361 of the PHS Act. For products with characteristics that raise significant concerns about clinical safety and effectiveness, FDA will require premarket approval. For products that pose lesser risks in the area of clinical safety and effectiveness, FDA will refrain from categorizing them as "biologics," "drugs," or "devices," and will not be applying premarket approval requirements. Instead, the agency plans to rely on section 361 of the PHS Act, which provides broad authority to promulgate regulations to control the spread of communicable disease.

Current Issues with Off-Label Use of Prescription Drugs

Gary G. Cacciatore, Pharm.D., J.D.
Assistant Professor Department of Clinical Sciences and Administration
University of Houston College of Pharmacy
Adjunct Professor
University of Houston Law Center

Off-label use of drugs occurs when a physician prescribes a drug in a manner not indicated in the drug's official labeling as approved by the Food and Drug Administration (FDA). Other terms that may be used to describe such uses are unapproved uses, unlabeled uses, or extra-label uses. The off-label use of a drug may include not only using a drug for an unapproved indication, but also using a drug in an unapproved dose or dosage form, and using a drug in an unapproved patient population.

Off-label prescribing covers a broad range of drug usage from truly experimental uses of drugs to appropriate and accepted medical therapy. The extent of off-label prescribing is remarkably high. The American Medical Association estimates that almost half of written prescriptions may be for off-label uses. In some medical specialties, such as oncology and pediatrics, the majority of prescriptions are written for off-label indications.

Although it is perfectly legal for physicians to prescribe drugs for off-label uses, the issue has become important recently in the context of FDA reform and in many state legislatures dealing with reimbursement issues. This article addresses FDA regulation of off-label prescribing and state regulation of reimbursement for off-label drug usage. Liability issues raised with off-label prescribing are beyond the scope of this article.

FDA Regulation

The FDA has repeatedly stated that it does not regulate the practice of medicine and therefore once an approved drug is on the market, a physician may prescribe that drug for any condition or in any manner the physician likes. The FDA does regulate manufacturers' promotion of off-label uses, however, and it is this regulation that has often come under criticism.

Until the recent passage of the FDA Modernization Act of 1997, drug manufacturers could not promote a drug product for a use or indication for which it did not have an FDA-approved indication. Such promotion would constitute misbranding of the drug product. Some argue that these restrictions prevented physicians from obtaining relevant and vital information about drugs and restricted the free flow of medical information. The FDA argued that the agency did not prohibit the dissemination of information, including information about off-label drug use through compendia, journal articles, continuing medical education programs, and professional meetings. In addition, the FDA did not prohibit a manufacturer from providing information regarding an off-label use when the information is requested by the physician. Critics counter that FDA initiatives have taken a broader view of what encompasses drug product promotion and advertising by taking a closer look at industry sponsored medical conferences and focus groups which discourage the dissemination of new information.

FDA's primary concern with permitting off-label promotion is that such uses have not been proven to be safe and effective. The agency points out that the efficacy standard for drug approval is one of the primary reasons that there is a strong sense of confidence in the drug products on the U.S. market today. Another major concern is the lack of incentive for companies to conduct or fund the necessary research to gain approval for new indications.

The FDA Modernization Act of 1997, signed into law by President Clinton on November 21, 1997, contains provisions that liberalize FDA's prohibitions against promotion of off-label drug use. Among other things, the new law allows companies to circulate journal articles and reference publications covering off-label uses provided they agree to complete studies of the indication within three years. This appears to be a compromise to allow some dissemination of off-label uses while addressing FDA's concerns about a lack of incentive to seek new indications.

Regulating Reimbursement

A separate but related issue with off-label drug use has developed around reimbursement policies of insurers and other third-party payers. In the past few years, a number of states have adopted off-label drug legislation that mandates insurance coverage for some or all off-label uses of drugs. Requirements vary by state with some addressing specific uses such as in oncology or AIDS and others mandating coverage for any off-label use.

Managed care organizations and insurers have generally opposed legislation which mandates coverage including these that mandate off-label drug use coverage. However, because off-label use of drugs is so prevalent, most insurers have adopted policies that specify criteria for when off-label uses will be covered. In fact the National Association of Insurance Commissioners has adopted a Model Off-Label Act which requires insurers to provide payment for off-label use of drugs if the use is recognized in (1)standard reference compendia, (2) peer-reviewed medical literature, or (3) by the U.S. Secretary of Health and Human Services. Of more concern to insurers and third-party payers is pending legislation in a few states that would expand reimbursement requirements to experimental uses for cancer and AIDS. Insurers have been adamant in fighting any legislation that would expand mandated coverage to experimental procedures and experimental uses of drugs.

Although there has been much litigation over insurance coverage for new therapies, such as high dose chemotherapy-autologous bone marrow transplant, there has been surprisingly little litigation involving off-label drug use. The public is becoming increasingly interested in reimbursement for off-label use, and it is expected that many more states will address the issue either through legislation or administrative rule.

Identifying the Limits of FDA Authority over Professional Practice: Compounding by Pharmacists

Joseph L. Fink III, B.S.Pharm., J.D.
Professor of Pharmacy and Professor of Health Administration
University of Kentucky

Extemporaneous preparation of finished dosage forms bearing active medicinal agents has been an integral part of the professional role of pharmacists for literally thousands of years. The ability to create a customized vehicle for delivery of a medication is unique to pharmacists - no other health professional has the ability to do this. Not surprisingly, therefore, efforts by the Food and Drug Administration to extend its jurisdiction to encompass these traditional professional activities of pharmacists have been met with vigorous opposition by pharmacists and their professional organizations.

This issue came to the fore in the early part of this decade when the FDA sought to ban the distribution of pure chemicals that could serve as active ingredients in finished dosage forms to pharmacists engaged in compounding on a large scale. In 1992, FDA Commissioner David Kessler, in remarks at the Annual Meeting of the American Pharmaceutical Association (APhA), indicated that FDA was not focusing on the legitimate activities of the vast majority of pharmacists engaging in the "traditional activity" of compounding. Rather the agency was directing its enforcement activities at "a growing number of establishments" found to be "misusing" their status as licensed pharmacies to manufacture and distribute unapproved new drugs as that phrase is defined in the Food, Drug and Cosmetic Act.

The factors that attracted the attention of FDA were producing the medicaments in advance of receiving a prescription, preparation of the dosage forms in large quantities, and promotional activities by the pharmacies designed to stimulate demand. The agency issued guidance to its field inspectors for enforcement of their view of the law in this area in a Compliance Policy Guide (CPG), i.e., a directive and interpretation of relevant law from headquarters. Interpretations of this document led to litigation in the federal courts in Texas, with the challenge based on the issue of whether the CPG equated to regulations that needed to be published for public comment prior to being finalized. The courts ruled that the CPG did not equate to a regulation and opportunity for public comment was not required.

The administrative challenge facing the agency is to craft a set of guidelines that will provide adequate specific guidance to the field enforcement staff while at the same time carving out the exception noted by Commissioner Kessler for the traditional activities of pharmacists engaging in legitimate practice of compounding in response to an individual request for a specific patient from an authorized prescriber.

While administrative activity on this topic has been relatively quiet lately, perhaps because FDA successfully transmitted the message about what it deemed to be unlawful conduct, the forum for consideration of these issues has shifted to the Congress. Legislation designed to reform FDA has passed this year and professional pharmacy organizations have successfully lobbied to have a provision clearly exempting legitimate compounding activities of pharmacists from FDA jurisdiction.

While some may look at this issue in light of the fact that less than one percent of prescriptions require compounding today and conclude that this is of little importance, that conclusion may miss the mark. If you are a patient with a special need that can best be met through an extemporaneously compounded dosage form bearing the medication you need, this issue might assume much greater importance than a superficial review would indicate. Hopefully, pharmacists will continue to be unfettered in their abilities to meet the unique needs of some patients through customized dosage forms.

Texas State Authority to Combat Health Fraud

Robert E. Reyna
Assistant Attorney General
Consumer Protection Division
Office of the Attorney General of Texas

The basis of the State of Texas' efforts to combat health fraud against its citizens is the civil authority of the Office of the Attorney General of Texas ("OAG") to seek injunctive relief to stop fraudulent promotions affecting public health. The OAG may also seek civil penalties and recover attorneys' fees and costs associated with suits to stop fraudulent health promotions.

Statutes enforced by and through the OAG provide protection to citizens from a wide range of fraudulent activities. Specific products and services that have been the subject of legal action by the OAG range from home manufactured and marketed drugs and devices to the promotions of major pharmaceuticals and medical device manufacturers.

The Texas Deceptive Trade Practices Act ("DTPA"), TEX. BUS. & COM. CODE ANN. Sections 17.01-17.826 (Vernon 1992), gives the Consumer Protection Division of the OAG authority, when it determines such proceedings would be in the public interest, to seek restraining orders as well as temporary or permanent injunctions when the OAG has reason to believe that any person is engaging, has engaged, or is about to engage in any act or practice declared to be unlawful by Section 17.47 of the DTPA. This authority has been used to stop promotions which have falsely represented the uses or benefits of health products or services, or have falsely claimed that such products or services have government approval.

The following are some examples of the types of health fraud which have been the subject of OAG action to protect the public health. The OAG has reached agreements with manufacturers requiring the removal from the marketplace of such products as a $30.00 hearing amplifier sold as a hearing aid without proper prior approval of the U.S. Food and Drug Administration ("FDA"). Manufacturers have agreed upon a finding of violations by the OAG to stop touting products such as pain relieving lotions promoted on the basis that they contain 24 ct. gold, as well as diabetes curing aloe vera drinks, cancer preventing fiber pills, and any number of weight loss concoctions, none of which had been proven either safe or effective.

The DTPA has also been used to enjoin the sale of products or services when material facts have been withheld from consumers with the intent to induce them into transactions they would not otherwise have entered. This authority has been used to force manufacturers to reveal important consumer purchasing information including disclosure that contact lenses were priced differently based on sale for daily or extended use even though they were exactly the same lenses. It has forced disclosure of financial connections between mail order prescription providers and pharmaceutical companies impacting on choice of prescription drugs, and disclosure of payments by pharmaceutical companies to pharmacists to lobby physicians to change patients' prescriptions from one company's drug to another.

The DTPA has also been used to stop companies from causing confusion as to affiliation or sponsorship or as to the certification of goods or services. The OAG has forced withdrawal of unapproved claims that one brand of hearing aids helps wearers distinguish speech better than other brands and disclosure that sonograms performed without medical necessity or a doctor's prescription can put expectant mothers at unnecessary risk constituting an unauthorized use of those devices. The OAG has obtained injunctions requiring disclosure that so called Chinese "herbal" remedies for arthritis were laced with prescription drugs and adulterated with lead and cadmium.

The Texas Food, Drug and Cosmetic Act ("TFDCA"), TEX. HEALTH & SAFETY CODE ANN. Sections 431.001-431.249 (Vernon 1992), provides that, upon a finding of a continuing violation or such a threat, the OAG may petition a district court for a temporary restraining order or other injunctive relief necessary to stop an immediate threat to the health and safety of the public. Substantial civil penalties of up to $25,000 per day per violation may be imposed by the court as well as the recovery of attorneys' fees and other reasonable expenses incurred in obtaining injunctive relief under the TFDCA.

The TFDCA prohibits the introduction into commerce of any food, drug or medical device which is adulterated (for example, products manufactured under unsanitary conditions) or which is misbranded and fails to bear adequate directions for use in its labeling. These restrictions have been employed by the OAG on behalf of the Texas Department of Health ("TDH") to enjoin the sale of dangerous food products unhealthy to eat because of contamination or pesticide residue, to enjoin the sale of products falsely claimed to be "all natural" or pills containing unsafe quantities of dietary supplement ingredients such as ephedrine. The authority of the TFDCA has also been used to remove dietary supplements from the shelves which were mislabeled and unapproved but contain claims of an ability to cure or treat disease conditions.

The TFDCA also prohibits the sale, offering for sale, or giving away of any unapproved drug or any medical device which is not marketed in compliance with the TFDCA requirements. The OAG has moved on behalf of TDH to force withdrawal of numerous "quack" and unapproved medical devices lacking FDA approval such as magnetic devices claimed to treat pain or cure medical conditions, brain wave "synchronizer" devices claimed to cure depression or speed learning which actually put users at risk of having seizures, as well as diagnostic and therapy devices claimed to treat everything from weight loss to sexual deviance.

Since a product is deemed to be a drug or medical device based on its intended use, product labels and promotional material as well as advertising may be used to establish the legal status of a product and thus its legality for sale. The OAG has brought suit to enjoin the sale and seek the destruction of pharmaceuticals and herbs produced in other countries under questionable circumstances which do not bear English language labeling meeting the TFDCA requirements for disclosure of ingredients, site of origin, and approved and substantiated uses.

Fraudulent marketers who attempt to promote health products for unsubstantiated uses can be required to remove their products from sale if they have failed to obtain a required federal and state pre-marketing clearance for claims that they intend to make in conjunction with advertising and sale. The OAG can and has sought detention of drugs and devices promoted for uses for which they have not been approved such as life support devices, baldness remedies, medical cures containing bleach, hydrogen peroxide and other dangerous ingredients, as well as numerous concoctions and potions claimed to be effective against HIV.

The interest of the public in new and "alternative" therapies and products has brought many new products and services into the marketplace. The statutory remedies described above provide a measure of protection against those products and promotions which seek to prey upon the public's natural but uniformed interest in protecting its health and the general assumption among members of the public that the advertising of health claims is regulated by government authorities charged with protecting the public health.

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