http://www.nytimes.com/2016/01/15/healt ... cking.html
F.D.A. Faulted for Problems With Drug Tracking
By SABRINA TAVERNISE JAN. 14, 2016
WASHINGTON — Federal investigators said Thursday that there were flaws in the way the Food and Drug Administration tracked drugs after they came to market, raising questions about the agency’s effectiveness as the country’s main drug overseer.
Once the agency approves a drug, it is required to monitor the drug’s safety as well as efforts by the company that makes it to study how the drug is doing in the marketplace, for example whether many patients are reporting problems while taking it. The investigators, from the Government Accountability Office, a nonpartisan investigative arm of Congress, looked at how the F.D.A. was doing with those tasks.
The answer was not very well.
“F.D.A.’s data on post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult,” the accountability office concluded in its report.
The office described its findings in a report commissioned by Representative Rosa DeLauro, Democrat of Connecticut. Ms. DeLauro said she wanted to evaluate the F.D.A.’s record on detecting problems with drugs at a time when increasing numbers of them are being approved under an expedited process.
The investigators said that about a quarter of the drugs the agency approved from October 2006 to December 2014 used at least one of the agency’s expedited programs. Critics of the fast-track system say it gives companies too much latitude to delay releasing longer-term evidence that a drug is safe and effective until after it is already on the market, a pattern they say increases patient risk. They say the new report is proof that such evidence is not making it into the public realm, a pattern that they argue blows a hole in the drug approval system.
“We are shortcutting an important part of the approval process in the hope that we get the information later, but now we’re finding out that’s not happening,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit consumer research group.
Supporters of the faster approval process say it does not increase risk and is needed in an age of rapidly advancing science when drugs are increasingly used on smaller patient populations.
The F.D.A. said it had investigated some of the same issues over the past few years and had already taken steps to correct the problems. The agency’s response was included in the report.
The investigators, who cited that F.D.A. response in their report, found that the majority of potential safety issues the agency had identified were not being tracked in its computer database for drug safety tracing. One reason, the agency had concluded, was that a change in policy had made it harder to enter the data. It found that staff members entered about two-thirds fewer issues into the system after that policy went into effect.
The computer system was also cumbersome and did not allow for the sorting of issues by disease type, patient population or F.D.A. action.
Investigators also found a backlog in the review of reports from companies on their progress on post-market studies. Over half of such reviews, associated with about 1,400 studies over a five-year period, were overdue, the investigators said.