The Food and Drug Administration is not receiving key information from drugmakers about whether some of the riskiest prescription drugs on the market are being used safely by doctors and patients, according a new report by government inspectors.
The report's findings suggest that pharmaceutical companies have largely ignored recent federal requirements designed to manage the safety of high-risk medications. That means American patients could be at greater risk of injury from dozens of drugs with serious side effects, ranging from birth defects to blindness.
The report from the Department Health and Human Services' Office of Inspector General is the first independent review of a five-year old program designed to give the FDA more control over prescription drugs. Beginning in 2008, the FDA gained the power to require manufacturers to develop risk-management plans for new drugs. The plans, known as Risk Evaluation and Mitigation Strategies, or REMS, can include a range of requirements:
— Patient brochures warning about drug side effects.
— Specialized training for doctors who prescribe some drugs.
— Limited distribution of drugs by certain hospitals or pharmacies
But when HHS inspectors reviewed the FDA's assessments of these plans, they found that the majority were apparently not meeting their goals of improving patient safety, according to the report released. Examples of goals for the plans include preventing drug exposure in pregnant women and educating doctors and patients about safety risks.
Only seven out of the 49 REMS plans reviewed by inspectors were meeting all their goals, according to the report. Inspectors said 21 of the plans were clearly not meeting their goals, while another 21 were missing too much information to draw any conclusion about their performance.
Among 19 plans for the riskiest drugs — which have requirements like special doctor training or limited distribution — only one was meeting all of its goals. Eight plans were not achieving their goals and another 10 were missing too much information to draw a conclusion.
The report does not identify specific companies or drugs, but the riskiest category includes medicines like Celgene's Revlimid, which is used to treat cancer of the white blood cells. The drug is known to cause severe birth defects, and women of child-bearing age must take contraception and regular pregnancy tests while taking the medication. All doctors and patients using the drug must also register with the manufacturer.
Another drug in the same class is Sabril from Lundbeck Pharmaceuticals, which is used to treat seizures. The tablets can cause permanent vision damage, and patients must undergo vision tests every three months while on the drug.
FDA spokeswoman Sandy Walsh said, "The FDA appreciates the areas of concern identified by the office of inspector general, and we're already actively working on them."
In many cases, inspectors say drug manufacturers are not submitting enough information about whether patients understand the risks of their drugs. One patient survey included responses from just three patients. In other cases, manufacturers did not include reports of adverse reactions to their drugs. Other companies failed to keep track of the number of doctors who had been certified to prescribe their products.
Inspectors point out that these drugs would probably have been rejected for safety problems without the REMS requirements.
"Some drugs would never have received initial FDA approval, or would have to be removed from the market if they did not have a REMS plan," said Sarah Langford, a program analyst in the inspector general's office.
Langford's report concludes that drugmakers are failing to follow up on REMS requirements because there is little downside. The FDA cannot penalize companies that don't submit all the information needed to tell whether REMS are working or not. The report recommends that the FDA ask Congress to give the agency the power to impose fines and other penalties on companies that don't cooperate.
While the FDA agreed with most of the report's findings, the agency was noncommittal on this last suggestion in its written comments about the report, stating that "this recommendation should be considered if another opportunity arises to pursue legislative changes."
The FDA's stance may reflect the historical reality that Congress rarely passes small fixes to existing health care laws, especially without pressure from the public.
Congress drafted the 2007 law that created the REMS requirements after a series of high-profile safety problems with drugs, including Vioxx. The blockbuster pain pill from Merck & Co. Inc. was pulled from the market in 2004, after studies linked it to risks of heart attack and stroke.
Date: February 13, 2013
Source: Associated Press