Drug firms plan safety studies to calm concerns

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 FDA.
Pfizer isn't alone. Bristol-Myers Squibb Co. came armed with similar plans to other meetings earlier 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 and Development. "When you have something new there is the theoretical potential for harm."
Merck & Co.'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 U.S. Food and Drug Administration, patients and doctors that they are seriously concerned about identifying risks.
"These days you have to walk in (to the FDA) with a Phase IV (post-marketing study) because if you don't agree to do it, your product approval may get delayed," said Dan Troy, a lawyer who was chief counsel at the FDA and is now in private practice.
Such tactics don't guarantee success. The FDA committee recommended approving Exubera -- the inhaled insulin Pfizer is developing with Sanofi-Aventis SA and Nektar Therapeutics -- but the agency has delayed the decision. Meanwhile, the FDA won't approve Bristol-Myers' diabetes medicine without additional 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 only require companies to conduct post-marketing studies 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.