WASHINGTON – Drug companies are dragging their feet on follow-up studies on drugs that receive accelerated approval from the Food and Drug Administration, Rep. Edward Markey, D-Mass., charged Tuesday.
Markey said that of 91 post-marketing studies required by the FDA, 42 have not been completed and half of those have not even been started.
Drugs designed for people with life-threatening illnesses can sometimes receive expedited approval to make them available more quickly. In those cases the companies are required to do a follow-up study of the people who use the drug to check for effectiveness and any side effects that may not have been seen in earlier, smaller studies.
“It is outrageous that drug companies and the FDA have been dragging their feet when it comes to conducting required post-marketing studies,” Markey said in a statement.
A drug tested on a few thousand people for a few months can’t be assumed to be safe for millions of people to use over the years to come, Markey said.
He also said a staff analysis of the work indicated many firms also have not disclosed information regarding post-marketing studies to their investors.
Markey said he plans to introduce a bill “to address the failures of the drug companies and the FDA to do their due diligence.”
An FDA spokeswoman said the agency has not yet seen the report.
A spokesman for trade group Pharmaceutical Research and Manufacturers of America said while the group has not had a chance to review Markey’s report, “we believe the regulatory program at FDA works well.”