Unapproved Yet Generating Profits
A report released Monday by the Government Accountability Office (GAO) finds many drugs currently on the market and being used by patients have not had postmarket surveillance completed for safety and efficacy.
That despite 2007 legislation passed by Congress giving the Food and Drug Administration (FDA) greater leverage over drug makers to complete their studies.
Since 1992, 90 of the drugs in the report have been essentially fast-tracked to get to patients with life-threatening illnesses such as H.I.V, AIDS, and cancer. Patients can use drugs under this approval even though they have not been tested for long-term benefit, such as an extended life.
The catch is that the drugs are eventually supposed to go through postmarket studies to confirm they are safe so they can stay on the market. The critical GAO report says studies have been completed for only two-thirds of the drugs and none have been pulled from the market.
The GAO says in a statement the FDA has the authority to expedite the withdrawal of a drug off the market if a study is not completed or if it fails to confirm a drug’s benefit, but it “has never exercised its authority, even when such study requirements have gone unfulfilled for nearly 13 years.”
The FDA’s response is that some of the drugs are the only ones on the market for the condition they treat and a blanket process won’t work.
"Millions of patients with serious or life-threatening illnesses have had earlier access to new safe and effective treatments," thanks to the program, the FDA said in its response to the report.
Of the 90 drugs, 15 have uncompleted studies for more than five years, while several have been lingering for more than eight years, among them:
- A drug such as ProAmatine (Shire Laboratories) for low blood pressure has gone unreviewed for more than 13 years. During that time it has generated more than $257 million in sales, reports CBS.
- Iressa (AstraZeneca) for lung cancer was approved by the FDA in 2003 after it was found to reduce the size of the tumor. Later studies found it did not extend life. Meanwhile hundreds of reports have come in of a sometimes fatal pneumonia. AZ says Iressa is not available to new patients.
"FDA has fallen far short of where it should be for patient safety," said Sen. Charles Grassley, R-Iowa, who requested the investigation.
Sidney Wolf, MD with the consumer group Public Citizen says the FDA policy is sending a message to companies that the agency has no teeth.
"The FDA has talked a lot about doing more enforcement, but this is an area where they're basically defending not enforcing the law,” he says.
The GAO says the FDA needs to clarify when it will revoke an approval to push along the review process. #