A U.S. congressman is claiming that the Food and Drug Administration's (FDA) system of rapidly approving new drugs is failing to ensure patient safety because drug companies are not doing the required follow-up studies.
According to Massachusetts Democratic senator Edward Markey many companies either stall or forgo completion of their required post-marketing confirmatory studies and the agency has not taken any action.
The FDA's accelerated approval process means that pharmaceutical companies wanting to manufacture drugs for life-threatening conditions can provide the government with less information about the drug's safety and efficacy than is usually required, but in return the companies are obliged to conduct follow-up studies to prove the drug benefits patients.
If research results fail to show the expected improvement, the FDA can withdraw that accelerated approval.
Markey says that although some companies do complete their required studies without any intervention from the FDA, the FDA has allowed many companies to stall or forgo completion of their required post-marketing confirmatory studies.
Markey, a senior member of the House of Representatives Energy and Commerce Committee, says it now appears that the system of accelerated approval is failing to ensure patient safety.
In his report which cites FDA data, he says 50 percent, or 21 out of 42 studies, that should have been completed have not even been started, and 46 percent of 91 studies started since 1992 are still incomplete.
Other critics have noticed that some companies are slow to do the post-market studies and point out that the FDA has never withdrawn the license of an accelerated-approved drug.
In defending their position FDA spokeswoman Susan Cruzan says that the accelerated approval process gets lifesaving drugs to patients who need them much faster.
PhRMA the drug industry lobby group also defended the fast-track process, and says in reality fewer than three percent of pharmaceutical products have been withdrawn from the market for safety reasons over the last 20 years. They say there has been no change in the withdrawal rate since the fast-track approval system was implemented 15 years ago. PhRMA considers the FDA's approval and monitoring efforts to be of international gold standard.
But the report from Markey's office is critical of the industry and says companies are waiting months and years before starting the studies they promised to do, and many companies have been selling products to the public for an average of one year and 10 months and up to six years and nine months without even initiating the required studies.
The report also says that it is difficult for doctors and patients to find out which drugs were approved quickly with the caveat that their safety be studied further once they are on the market, as by simply looking at a drug's label does not always make it clear what is the medication's status.
The report says the onus is on the patient or physician to find out whether the FDA has required further research on a product by visiting the FDA Web site, which is both difficult to find and to navigate.
The FDA itself admits there is a problem. In 2003, it published figures showing 349 studies for chemical-based drugs were completed, while 61 percent of the 1,339 outstanding studies had not been started.
At the time Dr. John Jenkins, head of the FDA's Office of New Drugs, said the FDA was planning to improve its tracking system.