The Problem with Fast-Tracking Drug Approvals: Pharmas Fail to Follow Up

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To get potentially lifesaving drugs to patients faster, the U.S. Food and Drug Administration is allowed to approve some drugs -- those that address unmet medical needs -- based on fewer trials than usual. But an advisory panel on Tuesday recommended that the FDA demand more from pharmaceutical companies that request expedited approvals for cancer drugs, both before -- and certainly after -- the approval.

Companies that get accelerated approval don't have to meet the FDA requirement of two randomized trials to show that a drug is safe and effective. But the companies are then supposed to complete additional post-marketing studies to verify the drug is as safe and effective as the initial results indicated.

A Poor Record of Following Up


It turns out that many of the companies have been slack on following through with their post-marketing commitments. Out of the 49 accelerated approvals for cancer drugs -- 29 of which were approved based on a single trial with no control arm to verify improvement -- only 55% have completed post-marketing studies verifying benefit, Nature reports, while 10.2% failed in post-marketing studies. Others have yet to conduct the trials.

Five of the drugs haven't completed the required testing more than five years after receiving their accelerated approval. If these are eventually found to be ineffective therapies, they'll already have been on the market for far too long benefiting only companies' coffers.

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The fast-track drug-approval process recently came into public attention when the FDA revoked the breast-cancer approval for Roche's blockbuster drug Avastin, which had been fast-tracked. While many were outraged by the FDA's decision, the regulatory body said that follow-up studies on Avastin failed to prove the drug works for breast cancer.

But at least Roche performed the study. On Tuesday, members of the Oncologic Drugs Advisory Committee grilled representatives of Eli Lilly (LLY), GlaxoSmithKline (GSK), Genzyme (GENZ), Amgen (AMGN) and Novartis (NVS) about their failure to complete such trials for six drugs.

The companies said that, despite trying to complete the follow-up studies, they couldn't find enough patients to generate reliable results. The FDA has also agreed that some trials promised by companies couldn't be performed because they became outdated.

Where Are the Teeth?

The FDA actually has the authority to fine a company or to revoke a drug's approval if the manufacturer fails to meet its commitments. But no such threats were made at Tuesday's meeting, according to MedPage Today. And without them, it's unclear what, if any, incentive drug companies have to actually follow through with their obligations. If anything, from the Avastin example, they may have incentive not to do so.

In Europe, The Wall Street Journal notes, a similar program grants approval for just one year, and the approval can then be renewed if the companies are making progress in meeting their post-marketing commitments.

Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products, suggests holding review meetings once a year. FDA advisers also discussed the possibility of tightening requirements for accelerated approval and requiring companies to begin confirmatory clinical trials before receiving approval.

Of course, there's also a downside to these types of changes: They might delay the approval process of these potentially lifesaving drugs.


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