This goose is better uncooked

FRAMINGHAM (09/24/2003) - Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation

Philip J. Hilts

Alfred A. Knopf/US$26.95

Life has never been simple for the U.S. Food & Drug Administration. Frequently attacked by business, intermittently stabbed at (front and back) by politicians, rocked by at least one internal scandal, and sometimes criticized by consumers, the FDA embodies America's uneasy relationship with regulation. We don't like it, but sometimes need it. Debate over just how much regulation to tolerate started with the Bill of Rights and hasn't stopped since.

So what is the proper role for the FDA? This question permeates Philip J. Hilts' fascinating retelling of the history of the FDA in Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation.

From its contentious start with the Pure Food and Drug Act of 1906 to commissioner David Kessler's renovation of the agency in the 1990s, Hilts takes readers behind the scenes of the FDA's great dramas: Harvey Wiley's "Poison Squad"; Teddy Roosevelt's conversion from critic to advocate and back to wary supporter; Frances Kelsey's success in preventing a U.S. thalidomide disaster; the kickback scandal of 1959 in the FDA's antibiotics division; Nixon appointee Ted Malek's "manual" for crushing FDA personnel, and more.

Imagine being one of Wiley's "Poison Squad" in 1903, when as chief chemist for the Department of Agriculture he fed all manner of noxious stuff to a group of volunteers to see what would happen. For five years, chef Wiley doled out doses of "adulterants" and preservatives mixed into the group's meals. Much was learned, but many never fully recovered. (Now, there's a project that could have used a good IRB!) Wiley eventually led the "new" FDA from his position as chief of the bureau of chemistry.

It is both amazing and frightening to realize how far we have come. The 1906 law had few real teeth -- it required only that ingredients be accurately labeled for interstate commerce. Its overhaul in 1938 added proof of safety as a requirement for new drugs. Not until 1962 was proof of drug effectiveness mandated (Kefauver-Harris Drug Amendments). This last law required testing 4,000 drugs already on the market -- an effort regarded as useless by many at the time. Medical devices weren't covered until 1976. Viewed from the present, it's tempting to think all the flagrant problems have been solved, but Hilts lobbies hard against this notion. For example, he describes in some detail the battle in the early 1980s to suppress data indicating that children who took aspirin when they had flu or chicken pox were far more likely to develop Reye's syndrome. Aspirin manufacturers feared any cautionary labeling would reduce sales needlessly. While the total number of Reye's cases was small, many were fatal, and the increased likelihood of getting the disease was large.

After nearly five years of wrangling over the data, including pressure from U.S. Health and Human Services chief Margaret Heckler not to label, the FDA was finally able to require cautionary labeling on aspirin in 1986. A federal court suit mounted by a private group helped break the logjam.

Clearly, the story of the FDA is complex. The agency is subject to manifold internal and external forces. Begun as the Food, Drug, and Insecticide Administration and shortened to the familiar FDA in 1930, the agency has been shuffled about from the Department of Agriculture (1906) to the Federal Security Agency (1940) to the Department of Health, Education and Welfare (1953) to the Public Health Service (1968) and finally to the Department of Health and Human Services (1988). The courts have given, taken, and shifted its authority several times.

Which brings us back to the question: What is the FDA's correct role? Hilts' answer can be roughly summarized as follows: Left unchecked, businesses -- drug- and food-related included -- worry more about profits than health. Enough companies have left a trail of damage to public health to warrant close watching and control by an independent agency. The FDA's rightful role is to challenge claims in a vigorous scientific effort to safeguard public health.

He's even included an epilogue, "Greed and Goodness," to illustrate the dark side of human nature. In it, he cites Wharton School (University of Pennsylvania) Professor J. Scott Armstrong's experiments showing students consistently making unethical decisions.

Don't be put off by the obvious slant. This is a wonderful book, and even though Hilts' politics occasionally gets in the way, it raises important questions. Is the FDA's best role to protect health or to facilitate the introduction of new therapeutics? Should the FDA be a vigorous watchdog, as Hilts suggests, or the lapdog many staunch free-marketers prefer? In the end, this may be the wrong question.

The truth is that most pharmaceutical companies recognize that a strong FDA is a bit like the goose that laid the golden egg. The confidence it has created among consumers has led directly to huge markets. People buy and use drugs far more eagerly because they know the FDA has vetted them. Kill the goose and lose the egg. Read this book.

SIDEBAR

Select Milestones in U.S. Food and Drug Law (1880-1949)

For a more complete listing, visit www.fda.gov/opacom/ backgrounders/miles.html.

1880 PETER COLLIER, chief chemist, U.S. Department of Agriculture, recommends passage of a national food and drug law, following his own food adulteration investigations. The bill was defeated, but during the next 25 years more than 100 food and drug bills were introduced in Congress.

1883 HARVEY W. WILEY becomes chief chemist, expanding the Bureau of Chemistry's food adulteration studies. Campaigning for a federal law, Wiley is called the "Crusading Chemist" and "Father of the Pure Food and Drugs Act." He retired from government service in 1912 and died in 1930.

1906 The original FOOD AND DRUGS ACT is passed by Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods, drinks, and drugs. The MEAT INSPECTION ACT is passed the same day.

1914 THE HARRISON NARCOTIC ACT requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record keeping for physicians and pharmacists who dispense narcotics.

1927 The Bureau of Chemistry is reorganized into two separate entities. Regulatory functions are located in the FOOD, DRUG, AND INSECTICIDE ADMINISTRATION, and nonregulatory research is located in the BUREAU OF CHEMISTRY AND SOILS.

1937 ELIXIR OF SULFANILAMIDE, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.

1938 THE FEDERAL FOOD, DRUG, AND COSMETIC (FDC) ACT of 1938 is passed by Congress, containing new provisions: extending control to cosmetics and therapeutic devices; requiring new drugs to be shown safe before marketing -- starting a new system of drug regulation; eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases; providing that safe tolerances be set for unavoidable poisonous substances; authorizing standards of identity, quality, and fill-of-container for foods; and authorizing factory inspections.

1940 The FDA IS TRANSFERRED from the Department of Agriculture to the Federal Security Agency, with Walter G. Campbell appointed as the first Commissioner of Food and Drugs.

1949 The FDA publishes GUIDANCE TO INDUSTRY for the first time. This guidance, "Procedures for the Appraisal of the Toxicity of Chemicals in Food," came to be known as the "black book."

1950 In ALBERTY FOOD PRODUCTS CO. v. U.S., a court of appeals rules that the directions for use on a drug label must include the purpose for which the drug is offered. Therefore, a worthless remedy cannot escape the law by not stating the condition it is supposed to treat.

1962 THALIDOMIDE, a new sleeping pill, is found to have caused birth defects in thousands of babies born in western Europe. News reports on the role of Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market arouse public support for stronger drug regulation. KEFAUVER-HARRIS DRUG AMENDMENTS passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to the FDA the effectiveness of their products before marketing them.

1970 In UPJOHN v. FINCH, the Court of Appeals upholds the enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy. The ENVIRONMENTAL PROTECTION AGENCY is established and takes over the FDA program for setting pesticide tolerances.

1976 VITAMINS AND MINERALS AMENDMENTS ("Proxmire Amendments") stop the FDA from establishing standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency.

1983 The ORPHAN DRUG ACT is passed, enabling the FDA to promote the research and marketing of drugs needed for treating rare diseases.

1987 INVESTIGATIONAL DRUG REGULATIONS ARE REVISED to expand access to experimental drugs for patients with serious diseases with no alternative therapies.

1988 The FOOD AND DRUG ADMINISTRATION ACT of 1988 officially establishes the FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate.

1992 The PRESCRIPTION DRUG USER FEE ACT requires drug and biologics manufacturers to pay fees for product applications and supplements and other services. The act also requires the FDA to use these funds to hire more reviewers to assess applications. MAMMOGRAPHY QUALITY STANDARDS ACT requires all mammography facilities in the United States to be accredited and federally certified.

1997 The FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938.

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