Will The FDA Stand Its Ground Against Big Pharma On This Change In Course?
Leila Abboud and Anna Wilde Mathews, of The Wall Street Journal ("WSJ"), reported on October 18, 2005 that the FDA is considering whether drug companies submitting new psychiatric drugs for approval should be required to perform longer drug studies than have had to be done previously.
In their WSJ article, Ms. Abboud and Ms. Mathews point to documents they found on the FDA's web site which indicate that for the past six months the FDA has been asking drug companies to provide "longer-term efficacy data" for psychiatric drugs intended for the treatment of chronic conditions. According to Thomas Laughren, acting director of the FDA's division of psychiatry products, however, the change in course has met with some resistance from drug companies and clinical researchers who contend that such a change will slow the development process for new psychiatric drugs.
David Michelson, executive director for neuroscience medical research at Eli Lilly & Co., called the FDA's change in course a "stepping up of requirements for psychiatric drugs" and said further:
If you require that chronic studies be done prior to filing a new drug application, you have potential to delay the approval of new drugs significantly. That has implications for patients.
The FDA will discuss the intended change requiring longer drug studies of new psychiatric drugs -- namely, antidepressants, antipsychotics, and other drugs for long-term psychiatric conditions -- at an advisory panel meeting scheduled for October 25, 2005. The discussion will include how such studies should be designed, about which the FDA's Dr. Laughren commented: "It's a very important clinical question."
It is reported that representatives of several drug companies, including Eli Lilly & Co. and GlaxoSmithKline PLC, plan to testify at this FDA advisory panel meeting.
Up until the recent change in course, Dr. Laughren said that the FDA only required relatively short studies, typically less than three months, before a psychiatric drug might get marketing approval from the FDA. Thereafter, the submitting drug company would conduct post-marketing studies concerning safety and efficacy.
According to the October 2005 WSJ article by Abboud and Mathews:
Now, the FDA is considering whether such longer-term studies, which can take two to three years altogether for depression patients, should be required before a drug goes on the market. The agency has long been moving toward such a requirement, Dr. Laughren said. But the limited data available during last year's debate over possible risks of antidepressants to young patients, which centered on short-term trials, helped to spark action on the issue, Dr. Laughren said.
Apparently, some European Union drug regulators already require that the longer drug studies -- similar to what the FDA is proposing -- be submitted prior to the granting of market approval for new psychiatric drugs in certain EU countries. For this reason and others, the WSJ article concluded that the FDA's new proposal, or approach, regarding psychiatric drug approval would not result in significant increased costs for the submitting drug companies.
We will watch to see whether the FDA stands its ground against Big Pharma on this change in course as regards the approval of new psychiatric drugs.
(Posted by: Tom Lamb)