FDA – Drug Industry Relationship Too Close for ComfortNov 26, 2007 | Parker Waichman LLP
Is the Food and Drug Administration (FDA) to close to the drug companies it regulates? Scandals involving Defective drugs over the past few years seem to indicate that the FDA is indeed too cozy wit the drug industry.
Case in point: pharmaceutical maker Wyeth withdrew two popular obesity drugs from the market following links to thousands of cases of severe heart and lung damage and several deaths. The recall ended the fen-phen diet-drug craze, but only after approximately eight million prescriptions were written. Wyeth insisted the problem was small and could not be proved but set aside nearly $21 billion for legal fees and claims. Case documents revealed Wyeth received reports of serious side effects and deaths linked to their diet drugs. The Vioxx crisis-involving Merck and the FDA's negligence-were the same as in the fen-phen recall and revealed serious problems within the pharmaceutical industry and the FDA. Avandia was linked to amplified risk of heart attacks, yet the FDA just voted to increase label warnings while keeping it on the market.
The FDA has been criticized for its handling of nearly a dozen other drugs and medical devices pulled from the market, including the cholesterol drug Baycol, pain reliever Bextra, and the Guidant heart defibrillator. Investigations revealed the FDA and drug companies were slow to react to problems; that the FDA tried to quiet agency doctors. FDA and drug-industry critics complain the relationship between medical researchers and drug companies is too close and that the industry tried to turn medical education seminars into drug-promotion campaigns.
Congress recently passed a drug-safety bill to promote adverse reaction tracking, a move the drug industry fought for years. An FDA panel recommended popular over-the-counter cough and cold medications should not be used by children under six, stating there is insufficient evidence the drugs work and they may not be safe for young children. Is this a true fix or a public-relations move? Many believe the latter, and the FDA's actions regarding other defective drugs are one reason for these drugs. For instance, Pondimin and Redux were withdrawn amid lawsuits over links to a fatal lung disease and heart-valve damage. Patients were mostly women; one in her 20s died months after her claim against the company was settled and another, in her 40s, died during litigation. Ultimately, about 300,000 nationwide claims were collected into the federal case and settled based on patients' ages and illness severity. Thousands of others sued in state courts, which led to public disclosure of thousands of pages of documents showing what the FDA knew, when they knew, and how they resisted taking action until the medical community spoke up and a barrage of news stories were released.
The office that promotes drug approvals is still twice the size and as important as the office for drug safety. The same people who approve drugs also help decide whether those drugs should be withdrawn. Does this create a conflict of interest? Some feel that the imbalance of power between the Office of New Drugs and Office of Drug Safety is a major weakness in the system.