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Trump Proposals Put Profit Over Public Safety

By: Stewart Cohen @ Feb 6, 2017

 

TRUMP PROPOSALS TO SLASH FDA REGULATION  PUTS PHARMA INDUSTRY PROFITS OVER PUBLIC SAFETY

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. I write to ask that you take personal action, and that you write the White House and your Republican congressional delegation and request that they oppose these initiatives.

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 the safety protections established in the last 111 years underscores the absolute necessity to protect the public through rigorous regulation and vigilant enforcement**:

  • In 1911 the Supreme Court of the United States (SCOTUS) rules in U.S. vs. Johnson that the 1906 food and drug act does not outlaw false medical claims but only false and misleading statements about the ingredients or identity of a drug;
  • In 1912 Congress passes the “Sherley Amendment” in response to the holding in U.S. vs. Johnson, and the act (as amended) outlaws labeling medicines with false medical claims;
  • In 1933 the FDA recommends a total revision of the outdated 1906 Food and Drugs Act to keep up with the developments in medicine and science, and for protection of the public; 

*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 scohen@cprlaw.com.

**http://www.fda.gov/downloads/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandingover-the-countermedicines/ucm093550.pdf)

  • In 1937, 107 people (including many children) are killed after consuming a liquid form of Elixir Sulfanilamide, a drug used to treat streptococcal infections. This drug had been used safely for some time in tablet and powder form. In response to a consumer demand for a liquid version to give children, the manufacturer, S.E. Massengill Co., in Bristol, Tenn., experimented and found that sulfanilamide would dissolve in diethylene glycol. The problem was that the new formulation had not been tested for toxicity before it was sold. At the time the law did not require that safety studies be done, underscoring the need to establish drug safety before marketing;
  • In 1938 Congress passed the Federal Food, Drug and Cosmetic (FDC) Act which requires that manufacturers establish that new drugs are safe before they sold. This started a new system of drug regulation. The Act also requires that safe limits be set for unavoidable poisonous matter and allows for factory inspections by the agency;
  • In 1938 the Federal Trade Commission is given power to oversee advertising for all FDA-regulated products except prescription drugs;
  • In 1938 the FDA requires that sulfanilamide and other dangerous drugs be administered under the direction of a physician;
  • In 1941 nearly 300 deaths and injuries result from the use of sulfathiazole tablets, an antibiotic, tainted with a sedative, phenobarbital. In response, the FDA regulates manufacturing and quality controls, which leads to the development of good manufacturing practices (GMP);
  • In 1948 SCOTUS rules in US vs Sullivan that FDA jurisdiction extends to retail stores, thereby allowing FDA to stop illegal sales of drugs, including barbiturates and amphetamines;
  • In 1950 the 9th Circuit Court of Appeals in Alberty Food Products Co v US rules that the directions for use on a drug label must include the purpose for the use of the medication;
  • In 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;
  • In 1952 a nationwide investigation by FDA reveals that chloramphenicol, an antibiotic, caused nearly 180 cases of often deadly blood diseases. Two years later the 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;
  • In 1962 Thalidomide, a new sleeping pill, causes severe birth defects of the arms and legs in thousands of babies born in Western Europe. The US 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;
  • In 1962 Congress passes the Kefauver-Harris Drug Amendments. For the first time, these laws require drug makers prove their drug works before FDA can approve it for sale;
  • In 1962 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;
  • In 1966 the FDA contracts with the National Academy of Sciences/National Research Council to measure the effectiveness of 4000 marketed drugs approved on the basis of safety alone between 1938 and 1962;
  • In 1966 the Fair Packaging and Labeling Act requires all consumer products, in interstate commerce, to be honestly and informatively labeled;
  • In 1968 the 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;
  • In 1970 the FDA requires the first patient package insert, and medicines must come with information for the patient about risks and benefits;
  • In 1972 non-prescription medicine “over the counter” drug review begins to enhance the safety, effectiveness and appropriate labeling of drugs sold without prescription;
  • In 1973 SCOTUS upholds the 1962 drug effectiveness law and approves FDA’s action to control entire classes of products;
  • In 1982 FDA issues “tamper resistant” packaging regulations to prevent poisonings such as deaths from cyanide placed in Tylenol capsules, and Congress passes the Federal Anti-Tampering Act in 1983, making it a crime to tamper with packaged consumer products;
  • In 1984 the Drug Price Competition and Patent Term Restoration Act (the “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;
  • In 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;
  • In 1991 a dozen federal agencies adopt a policy to protect human subjects in medical research, known as the “common rule”.
  • In 1993 the FDA launches MedWatch a system designed to collect reports from health professionals regarding problems with drugs and other medical products.
  • In 1993 the 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;
  • In 1998 the FDA introduces the Adverse Event Reporting System (AERS) a computerized database designed to store and study safety reports on already marketed drugs;
  • In 1998 the “demographic rule” requires that a marketing application review data on safety and effectiveness by age, gender and race;
  • In 1998 the Pediatric Rule requires drug makers of selected new and existing drugs to conduct studies on drug safety and effectiveness in children;
  • In 1999 the Drug Facts Label for Over the Counter drug products requires that all non-prescription drug labels have information in a standard format. These drug facts labels are designed to give the user easy to find information;
  • In 2003 he Pediatric Research Equity Act gives FDA the right to ask drug companies to study the effectiveness of new drugs in children;
  • In 2004 the FDA advises medical professionals to limit the use of a pain reliever called Cox-2 (Vioxx) a non-steroidal anti-inflammatory drug (NSAIDS). Studies had shown that long term uses raised chances of heart attacks and strokes. The warning is also added to the over the counter label;
  • In 2004 Medicines used in hospitals must have a bar code to prevent patients from receiving the wrong medicine;
  • In 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.

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