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Pharma bracing for tougher FDA guidance on trials

November 2, 2009 |

Transparency welcomed, but threat of added costs creates concerns.

Pharmaceutical companies in New Jersey and elsewhere face more stringent requirements from the Food and Drug Administration on disclosures of mishaps in clinical trials.

And while industry groups and advisers have broadly welcomed the increased transparency and the move toward safer drugs, they want these actions to strike a balance with the costs of complying with them.

As of Sept. 27, the FDA requires drug manufacturers to include the general public in disclosures on “adverse” and “serious adverse” events beyond the regulator and patients participating in trials, said Satish Tadikonda, president of Virtify Inc., in Cambridge, Mass., which provides compliance services to life sciences companies.

Adverse events are side effects like rashes or headaches, while serious adverse events are those that result in death, disability or life-threatening situations, among others, Tadikonda said.

“The playing field is leveled across the world,” Tadikonda said. “Previously, if you wanted to get competitive intelligence on a drug, you had to read numerous trade journals, and patients had to guess whether they could participate in a trial.” Now, the disclosures have to be posted at, a registry developed by the National Institutes of Health and the FDA.

Tadikonda said the regulator’s actions follow high-profile lawsuits, such as those involving Merck’s painkiller drug Vioxx and GlaxoSmithKline’s diabetes drug Avandia. He said his firm has worked with several New Jersey-based pharmaceutical companies, the FDA and the NIH to clarify and interpret the new rules.

The industry’s pre-eminent advocacy group, the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America, supports FDA’s move, and in October issued its own set of principles to achieve the goals set forth by the agency, according to Jeffrey K. Francer, its assistant general counsel.

But the new disclosure requirements would “necessarily increase the amount of expense in the drug-development process,” Francer said. “It is already enormously expensive, and it is important to make sure that the benefit of additional requirements outweighs the costs.”

Francer said striking a balance between regulatory requirements and compliance costs will be especially important as NIH defines the rules to post the results of clinical trials on the Web.

“The NIH should do so in a way that protects the confidential commercial information and trade secrets [of drug companies] and does not jeopardize companies that register [clinical trials] in the U.S.,” Francer said.

NIH could use specific steps to lower costs, for instance, an automated reporting process that would accept PDF submissions, Francer said. PhRMA has also advocated the International Conference on Harmonization’s format for summarizing clinical trails information, which is accepted by European and Japanese regulators.

The FDA requirement for greater disclosures on the clinical trials site comes as it faces a legal challenge for restraining companies on what they tell the public, said Linda Pissott Reig, an attorney specializing in life sciences at Porzio, Bromberg & Newman P.C., in Morristown.

Reig referred to a lawsuit filed by Allergan, of Irvine, Calif., in early October against the FDA, seeking to distribute information to physicians on the off-label uses of its wrinkle-smoother drug Botox. Allergan is required to put out warnings about the risks of the off-label uses of Botox, but now wants to be allowed to “proactively share truthful and relevant information with the medical community” as well, according to a press release.

“Allergan claims that it is in a catch-22 situation in getting safety information out effectively,” Reig said. Calling the lawsuit “a huge development,” she said companies like Allergan “cannot promote their products off-label, but there are limits to what safety information they can share.”

The latest FDA disclosure requirements could cause discomfort also to generic drug manufacturers, whose competitive edge comes with “an element of surprise,” Tadikonda said.

These companies typically operate by producing a generic alternative to a brand-name drug just before its patent expires. Generic drug makers are concerned they now have to disclose information relating to bioequivalence studies the FDA may require.

“Earlier, they could do that in a quieter way,” Tadikonda said.

By Shankar P.

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