Healthy Skepticism Library item: 2661

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Aboud L, Matthews A.
FDA May Require Longer Studies Before Clearing Psychiatric Drugs
The Wall Street journal 2005 Oct 18
http://proquest.umi.com/pqdweb?did=912743641&Fmt=3&clientId=20485&RQT=309&VName=PQD

Keywords:
FDA psychiatric

Notes:

Ralph Faggotter’s Commnets:
David Michelson, executive director for neuroscience medical research at Lilly, said that making companies submit the long-term studies earlier would represent a “stepping up of requirements for psychiatric drugs.”
“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,” said Dr. Michelson. “That has implications for patients.”

Yes, Mr Michelson, and judging from experience, those ‘implications’ are almost certain to be positive ones for the patients!

Full text:

Wall Street Journal
FDA May Require Longer Studies Before Clearing Psychiatric Drugs
Leila Abboud and Anna Wilde Mathews. Oct 18, 2005. p. D.7

Federal regulators are considering requiring drug makers to perform longer-term studies of many psychiatric medications before they can be approved for marketing in the U.S.

In documents posted on its Web site, the Food and Drug Administration said for the past six months, it has been asking manufacturers to provide “longer-term efficacy data” for psychiatric drugs that treat chronic conditions. But the shift has met with resistance from companies and some researchers, who have said it will slow the process of developing new drugs, said Thomas Laughren, acting director of the agency’s division of psychiatry products.

The move toward longer-term studies of antidepressants comes as the FDA has been under pressure to show that it places a strong emphasis on drug safety — though the push for new data for the psychiatric drugs is focused largely on how well they work. Industry officials have said they believe agency reviewers have been more cautious in recent months because of the scrutiny, but the FDA has said there has been no shift in approval times.

In a meeting scheduled for next Tuesday, the FDA will ask an advisory committee about its move toward longer-term studies of antidepressants, antipsychotics and other drugs for long-term psychiatric conditions, including how such trials should be designed. “It’s a very important clinical question,” Dr. Laughren said.

In the past, Dr. Laughren said, the agency has only required relatively brief studies that typically lasted less than three months before a drug’s approval. After drugs went on the market, manufacturers would often complete longer-term research, such as “withdrawal” studies in which some patients would be taken off the drug to see if they showed signs of renewed symptoms, after which they would be given the medication again.

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.

Representatives of several drug companies, including Eli Lilly & Co. and GlaxoSmithKline PLC, plan to testify at the FDA meeting.

David Michelson, executive director for neuroscience medical research at Lilly, said that making companies submit the long-term studies earlier would represent a “stepping up of requirements for psychiatric drugs.”

“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,” said Dr. Michelson. “That has implications for patients.”

Requiring that studies of chronic use of psychiatric drugs be done earlier wouldn’t impose significant new costs for the industry, he added, because most companies eventually do such clinical trials. Some countries in Europe require such long-term data be submitted prior to approval, he said.