On February 1, 2017, President Trump promised the nation’s top drug companies that he would slash regulations at the Food and Drug Administration to make it easier for them to manufacture and sell products in the United States. In reality, this means that the Trump administration, with the support of a Republican-controlled Congress, intends to roll back consumer protections on drugs, cosmetics and dietary supplements and that will enable the pharmaceutical industry to put its profits over patient safety concerns. If the history of the marketing and sales of medicine in the last century has taught us anything, surely it is that regulation and oversight is crucial for public safety.
Before the 20th century, there were few federal laws regulating the contents and sale of pharmaceuticals. A loose patchwork of state laws provided little or no protection against the sale of dangerous, untested products – as well as unethical sales practices, such as misrepresenting the benefits of and ingredients in purported “medicine.” In 1906, President Theodore Roosevelt signed into law the first federal "Food and Drug Act," which prohibited the sale of "adulterated" and “misbranded” pharmaceuticals. A short history on the safety protections established in the last 111 years underscores the absolute necessity to protect the public through rigorous regulation and vigilant enforcement. From the FDA:
- “1911- In U.S. v. Johnson, the Supreme Court rules that the 1906 Food and Drugs Act does not outlaw false medical claims but only false and misleading statements about the ingredients or identity of a drug.
- 1912 - Congress passes the Sherley Amendment to overcome the ruling in U.S. v. Johnson. The Act outlaws labeling medicines with fake medical claims that is meant to trick the buyer.
- 1933 - FDA recommends a total rewrite of the out-of-date 1906 Food and Drugs Act.
- 1937 - Elixir Sulfanilamide, contain the poisonous liquid, diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to pass the pending food and drug law.
- 1938 - Congress passes The Federal Food, Drug, and Cosmetic (FDC) Act of 1938, which requires that new drugs show safety before selling. This starts a new system of drug regulation. The Act also requires that safe limits be set for unavoidable poisonous matter and allows for factory inspections. The Federal Trade Commission is given power to oversee advertising for all FDA regulated products except prescription drugs. FDA states that sulfanilamide and other dangerous drugs must be given under the direction of a medical expert. This begins the requirement for prescription only (nonnarcotic) drugs (see 1951 Durham-Humphrey amendment).
- 1941 - Nearly 300 deaths and injuries result from the use of sulfathiazole tablets, an antibiotic, tainted with the sedative, phenobarbital. In response, FDA drastically changes manufacturing and quality controls. These changes lead to the development of good manufacturing practices (GMPs).
- 1948 - The Supreme Court rules in U.S. v. Sullivan that FDA jurisdiction extends to retail stores, thereby allowing FDA to stop illegal sales of drugs by pharmacies including barbiturates and amphetamines.
- 1950 - In Alberty Food Products Co. v. U.S., a U.S. Court of Appeals rules that the directions for use on a drug label must include the drug’s purpose.
- 1951 - Congress passes the Durham-Humphrey Amendment, which defines the kinds of drugs that cannot be used safely without medical supervision. The amendment limits sale of these drugs to prescription only by a medical professional. All other drugs are to be available without a prescription.
- 1952 - A nationwide investigation by FDA reveals that chloramphenicol, an antibiotic, caused nearly 180 cases of often deadly blood diseases. Two years later FDA engages the American Society of Hospital Pharmacists, the American Association of Medical Record Librarians, and later the American Medical Association in a voluntary program of drug reaction reporting.
- 1962 - Thalidomide, a new sleeping pill, causes severe birth defects of the arms and legs in thousands of babies born in Western Europe. The U.S. media reports on how Dr. Frances Kelsey, a FDA medical officer, helped prevent approval and marketing of Thalidomide in the United States. These reports stirred up public support for stronger drug laws.
- 1962 - Congress passes the Kefauver-Harris Drug Amendments. For the first time, these laws require drug makers to prove their drug works before FDA can approve them for sale. The Advisory Committee on Investigational Drugs meets for the first time. This was the first meeting of a committee to advise FDA on product approval and policy on an ongoing basis.
- 1966 - FDA contracts with the National Academy of Sciences/National Research Council to measure the effectiveness of 4,000 marketed drugs approved on the basis of safety alone between 1938 and 1962. The Fair Packaging and Labeling Act requires all consumer products, in interstate commerce, to be honestly and informatively labeled.
- 1968 - FDA forms the Drug Efficacy Study Implementation (DESI) to carry out recommendations of the National Academy of Sciences Investigation of the effectiveness of drugs first sold between 1938 and 1962.
- 1970 - FDA requires the first patient package insert, medicines must come with information for the patient about risks and benefits.
- 1972 - Over-the-Counter Drug Review begins to enhance the safety, effectiveness and appropriate labeling of drugs sold without prescription.
- 1973 - The U.S. Supreme Court upholds the 1962 drug effectiveness law and approves FDA’s action to control entire classes of products.
- 1982 - FDA issues Tamper-resistant Packaging Regulations to prevent poisonings such as deaths from cyanide placed in Tylenol capsules. Congress passes the Federal AntiTampering Act in 1983, making it a crime to tamper with packaged consumer products.
- 1984 - Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) increases the availability of less costly generic drugs by allowing FDA to approve applications for generic versions of brand-name drugs without repeating the research that proved the safety and effectiveness of the brand-name drugs. The Act also allowed brand-name companies to apply for up to five years additional patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process.
- 1989 - The FDA issued guidelines asking drug makers to decide if a drug is likely to have usefulness in elderly people and to include elderly people in studies when applicable.
- 1991 - In 1981, the FDA and the Department of Health and Human Services published a policy on protecting people in research. In 1991, this policy is adopted by more than a dozen federal agencies involved in human subject research and becomes known as the Common Rule.
- 1993 - FDA launches MedWatch, a system designed to collect reports from health professionals on problems with drugs and other medical products. FDA issues guidelines for measuring gender differences in responses to medication. Drug companies are encouraged to include patients of both sexes in their research of drugs and to study any gender-specific effects.
- 1988 - FDA introduces the Adverse Event Reporting System (AERS), a computerized database designed to store and study safety reports on already marketed drugs. The Demographic Rule requires that a marketing application review data on safety and effectiveness by age, gender, and race. The Pediatric Rule requires drug makers of selected new and existing drugs to conduct studies on drug safety and effectiveness in children.
- 1999 - Creation of the Drug Facts Label for OTC drug products. The law requires all overthe-counter drug labels to have information in a standard format. These drug facts labels are designed to give the user easy-to-find information.
- 2003 - The Pediatric Research Equity Act gives FDA the right to ask drug companies to study the effectiveness of new drugs in children.
- 2004 - FDA advises medical professionals to limit the use of a pain reliever called Cox-2, a nonsteroidal anti-inflammatory drug (NSAIDs). Studies had shown that long-term use raised chances of heart attacks and strokes. The warning is also added to the over-the counter NSAIDs’ Drug Facts label. Medicines used in hospitals must have a bar code to prevent patients from receiving the wrong medicine.
- 2005 - The Drug Safety Board is formed, consisting of FDA staff and representatives from the National Institutes of Health and the Veterans Administration. The Board advises the Director, Center for Drug Evaluation and Research, FDA, on drug safety issues and works with the agency in sharing safety information to health professionals and patients.”
Against this background and history, President Trump’s proposal reflects no knowledge regarding the FDA’s essential role in protecting public health and safety, which can only be explained by his placing a higher value on profits over protection. The fact of the matter is that if these health and safety regulations were done away with as the President suggests, it would require new laws and regulations to be passed.
For example, consider proposals for streamlining the process for new drug approvals. The fact is that the FDA has already loosened the approval process for new drugs in recent years, but the question is to what end.
As recently reported in the New York Times, “streamlining drug approvals sounds good, but the agency has already weakened approval standards and patients are paying the price — hugely expensive drugs that don’t even work,” according to Diana Zuckerman, president of the National Center for Health Research, a Washington research group that advocates strong safety and efficacy standards. She recently studied expensive new cancer drugs and found that many did not help patients feel better or live longer.
And now the call to action. This is on President Trump’s agenda, and the votes needed to enact this plan will be strictly along party lines in the Republican-controlled Congress. Accordingly, Republican votes will be needed to prevent the “deregulation” of FDA health and safety protections. If you wish to oppose this initiative, write to your Republican U.S. Senators and members of Congress and tell them of your opposition.
Stewart Cohen is a trial lawyer at the law firm of Cohen, Placitella & Roth, P.C. where he has worked relentlessly as an advocate on behalf of his clients for over thirty years. Mr. Cohen focuses his practice on complex civil litigation, including representation of severely disabled children and claims against drug manufacturers for injury victims. His firm has offices throughout Pennsylvania and New Jersey, and he can be reached at email@example.com.