Washington Editor

WASHINGTON - Drugmakers are continuing to disappoint when it comes to their post-approval study commitments, according to industry critics who seized on the FDA's latest report on the matter as reason to give the agency more power.

"For years, we've seen a real lack of urgency on this," Bill Vaughan, a senior policy analyst with Consumers Union, told BioWorld Today. "Once the horse is out of the barn, the horse does what it wants."

According to findings issued by the FDA on Friday, of the more than 1,600 post-approval study commitments for products approved through biologics license applications, new drug applications and abbreviated new drug applications, only 220 have been completed and submitted to the FDA through Sept. 30. That's about 13 percent. Among other findings, 274 of the studies, or 17 percent, are under way and on schedule through that date.

Federal law mandates an annual update on the studies, also known as Phase IV trials, which the agency uses to gather additional information about a drug's safety, efficacy or optimal use.

Nearly two-thirds of Phase IV trials, totaling 1,026, had yet to begin as of Sept. 30. The FDA classifies them as pending, since they've not yet passed their planned initiation dates. And in defense of companies with commitments in that category, it takes them time to design protocols acceptable to the FDA and recruit patients.

"We think this highlights the need for Congress to fund the FDA at a sufficient level to speed the process of reviews of these Phase IV studies," said Paul Winters, a spokesman for the Biotechnology Industry Organization. He noted that the agency's report does not distinguish the stage of readiness those pending studies have reached, telling BioWorld Today that in some cases, companies must await FDA clearance of their trial designs before getting them under way.

Nevertheless, most damning are the 109 Phase IV studies that are delayed or behind schedule, 7 percent of the total.

Vaughan noted that some companies take advantage of the situation, because after getting their drugs approved, they "don't deliver on the other half of the deal. For consumers, that's disappointing." Those findings largely mirror data revealed a year ago.

He and other critics say this lack of adherence could be fixed on Capitol Hill, where some lawmakers have proposed giving the FDA more teeth to enforce Phase IV commitments.

Recently reintroduced legislation from Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) proposes to do just that. It contains provisions for the agency to levy monetary fines "large enough to catch a company's attention," Vaughan said. Another bill from Sens. Chris Dodd (D-Conn.) and Chuck Grassley (R-Iowa) includes similar language. "The power is there in these bills to get action on these things," Vaughan added.

At present, the agency lacks such punitive power and instead has more limited enforcement authority. A drug's approval could get pulled, but "you just can't do that," Vaughan said, because that so-called nuclear option hurts patients as much or more than it hurts the drugmaker.

Most post-approval commitments, which are more or less voluntary, are agreed to by companies and the FDA. Such agreements to conduct them can be reached either before or after product approval. In addition, in some cases, the FDA can require such studies: products approved under accelerated provisions, for example, for which agency documents say "it is generally expected" that study protocols are to be submitted before product approval.

Federal law requires the agency to report annually on the status of post-approval study commitments made by sponsors of approved drug and biological products. According to the regulations, once a commitment has been made, an applicant must report on its progress on the anniversary of the product's approval until the study is completed or terminated, and the FDA determines that the commitment has been fulfilled, no longer feasible or would no longer provide useful information.