Drug companies have yet to even begin nearly two in three of the follow-up studies they agreed to undertake once their medicines were on the market, according to a government tally released Friday.
Often the drugs received expedited approval from federal regulators on condition that the studies be carried out.
The Food and Drug Administration said in an annual report that, as of Sept. 30, 65 percent of the 1,231 so-called “post-marketing” drug studies that companies had pledged to carry out were still pending.
“That doesn’t mean they will never be started,” said Dr. John Jenkins, director of the FDA’s Office of New Drugs, explaining that 116 of the 797 studies were committed to during the 12 months ending in September. The clinical trials required under the commitments can take six months to a year to design and launch, he said.
Some studies had been committed to years earlier, but the FDA didn’t provide a breakdown.
The 797 pending studies represent a slight dip from the 812 still pending as of a year earlier, according to FDA documents. FDA spokeswoman Kathleen Quinn said the agency feels that “these numbers show drug companies are taking this thing seriously.”
Dr. Jerry Avorn, a Harvard Medical School professor and author of “Powerful Medicines,” in which he criticizes the FDA’s post-marketing system, said the numbers show the system is broken.
“This new information is an embarrassing continuation of similar reports issued by FDA each year on the appalling state of the medication safety studies it has 'mandated' drug manufacturers to perform. It is scandalous that of the supposedly active studies, about two-thirds haven’t even been started yet,” Avorn said.
Added authority
The FDA says it relies on the so-called Phase 4 studies to gather additional information about a drug’s safety, efficacy or use. The outcome of those studies can lead to changes in how a drug is made, prescribed and used. The FDA also can require the studies after it has approved a drug, including to better determine its safe use in children.
The report, posted to the FDA Web site, lists 231 studies as ongoing, 28 as delayed and three as terminated as of Sept. 30. Another 172 studies are listed as completed or terminated, with a final report submitted to the agency.
The report also tallies studies required of biological products, which include vaccines, blood components and transplant tissues. There, of 321 study commitments, 118 — or 37 percent — remained pending as of Sept. 30. Another 56 were completed by that date.
Sen. Charles Grassley, R-Iowa, and Sen. Christopher Dodd, D-Conn., introduced legislation last year that would give the FDA added authority to require drug companies to carry out studies of their drugs once they’ve been approved and are being sold.
The FDA plans to award a contract in coming weeks to evaluate and improve the process of how the studies are developed and implemented, Quinn said.