Healthy Skepticism Library item: 3254

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

Agovino T.
Drugs may face post-approval tests
Associated Press 2005 Dec 26
http://www.philly.com/mld/inquirer/business/13487137.htm

Keywords:
post-approval FDA

Notes:

Ralph Faggotter’s Comments:

Drug companies are offering to do voluntary post-approval studies on some new products.
Note that there is no obligation to complete these studies!

While post-approval studies are a good thing (and should be mandated), there is the risk that they will act as an inducement for the FDA to hasten approval of products which have not been properly evaluated prior to approval.

Full text:

Posted on Mon, Dec. 26, 2005
Drugs may face post-approval tests
By Theresa Agovino
Associated Press

NEW YORK – Pfizer Inc. was even more prepared than usual when it met with a federal advisory committee that would decide whether to recommend an inhaled insulin for approval.

As is typical, Pfizer offered the safety and effectiveness data collected from clinical trials, but it also showed plans for several studies to continue to monitor the drug’s safety should it be approved. Two have already started but weren’t far enough along to be included in the company’s application to the Food and Drug Administration.

Bristol-Myers Squibb Co. brought similar plans to other meetings this year.

Such strategies aren’t common, but experts said the trend is likely to become entrenched in an environment of heightened concern about drugs’ safety.

“I think this will be the norm,” said John LaMattina, president of Pfizer Global Research & Development. “When you have something new, there is the theoretical potential for harm.”

Merck & Co. Inc.‘s withdrawal of its pain reliever Vioxx last year continues to cast a pall over the industry. It showcased that no drug is completely safe and that side effects may not manifest themselves in clinical trials with several thousand people, but may when taken by millions.

Now, companies are attempting to design studies that will find problems sooner and show the FDA, patients and doctors that they are seriously concerned about identifying risks.

Such tactics don’t guarantee success. The FDA committee recommended approving Exubera – the inhaled insulin Pfizer is developing with Sanofi-Aventis S.A. and Nektar Therapeutics – but the agency has delayed the decision. Meanwhile, the FDA won’t approve Bristol-Myers’ diabetes medicine without more data.

Bristol-Myers said it could take five years to accumulate the data, and hasn’t decide whether to make the effort.

The FDA can require companies to conduct post-marketing studies only in limited circumstances, such as when a drug receives an expedited approval because it meets an unmet medical need such as certain kinds of cancer drugs. And there has been concern that even those aren’t completely in a timely fashion.

Otherwise, companies can commit to the studies but face no penalties should they fail to complete them.

But industry executives say companies are thinking about post-marketing-safety studies sooner in the development process and conducting them for already-approved drugs. Traditionally, post-marketing studies were conducted to prove a medication effective in treating a new condition or, more recently, to show superiority over a competing product.

Troy notes there is some self-interest to safety studies: They can help defend against lawsuits because they show a proactive approach to finding risks.

One way drug companies track the safety of their products is by setting up registries where doctors or hospitals are asked to monitor patients on certain drugs for side effects. Establishing such registries is the fastest-growing portion of business at Quintiles Transnational Corp., which conducts clinical trials for drug companies, said Hugo Stephenson, president of the company’s strategic-research services.

The gold standard of clinical trials is randomizing patients into two groups where one set gets a placebo and the other receives the medicine. But registries can be larger, less expensive, and quicker at finding problems, Stephenson said.

Pfizer pledged to do one register and three clinical trials for Exubera.

LaMattina said the FDA probably wanted to see such studies because the concept of inhaling insulin is novel, so there were bound to be concerns about how it affected the lungs.

Such studies aren’t necessary only for drugs with new mechanisms of action, LaMattina said. Pfizer is funding a study to determine whether its pain reliever Celebrex leads to more heart problems than other pain relievers. Two studies have linked Celebrex to heart-attack risks, and the drug belongs to the same class as Vioxx.

But regardless of a drug’s class or history, LaMattina envisions safety studies becoming a stalwart. “At the end of the day, these are the studies that patients and doctors want,” he said.