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The FDA should step back from its policy of requiring risk management plans (RMP) is part of the drug approval process,
according to a senior official — indicating a major change in the agency’s thinking on drug safety.
The FDA’s move to harmonize its approach to risk management with its European counterparts could potentially lead some products to be withdrawn from the market because of rising costs, an industry consultant said.
The FDA is growing increasingly concerned about its own practice of requiring companies to provide risk management plans (RMPs) as a condition of drug approvals, a high-ranking agency official said.
The FDA is growing increasingly concerned about its own practice of requiring companies to provide risk management plans (RMPs) as a condition of drug approvals, a high-ranking agency official said.
Rebuffed in his attempt to force a face-to-face meeting with an FDA special investigator, Sen. Chuck Grassley yesterday charged the agency with covering up problems with its review of the antibiotic Ketek and threatened to hold hearings on the way regulators determine the safety of drugs.
The FDA is failing in its mission of protecting human health by refusing to recall remaining supplies of drugs that have been withdrawn because of health risks, an activist group says.
The FDA will not change its warnings for pregnant women taking certain anti-hypertension medicines — even though a study it cosponsored shows an elevated risk of birth defects in the first trimester.
Long-acting bronchodilators — also known as long-acting beta-agonists (LABAs) — should be pulled off the market because patients are four to six times more likely to die from asthma symptoms and were hospitalized twice as often as patients on placebos, according to a study to be published in the June 20 issue of the journal Annals of Internal Medicine.
The FDA has made the “rare” decision to allow a drug to be sold after the product was pulled from the market due to serious health concerns, despite the agency’s acknowledgement that there will continue to be deaths related to the drug’s use, an official said.
While Merck is downplaying the significance of its misidentification of the statistical method it used to analyze data from the study that prompted the company to pull Vioxx from the market, this admission may weaken the company’s defense in the thousands of lawsuits it faces over the drug.