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 www.clinicaltrials.gov, 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 involvingMerck’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.-basedPharmaceutical 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.
Source: NJBiz
