Experts Call for Changes to FDA Drug Approval A group of advisers to the Food and Drug Administration, along with the The New England Journal of Medicine, are calling for changes to the FDA's drug-approval process. The advisers say the current process has problems from start to finish, and has made five recommendations.
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Experts Call for Changes to FDA Drug Approval

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Experts Call for Changes to FDA Drug Approval

Experts Call for Changes to FDA Drug Approval

Experts Call for Changes to FDA Drug Approval

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A group of advisers to the Food and Drug Administration, along with the The New England Journal of Medicine, are calling for changes to the FDA's drug-approval process. The advisers say the current process has problems from start to finish, and has made five recommendations.

ROBERT SIEGEL, host:

From NPR News, this is ALL THINGS CONSIDERED. I'm Robert Siegel.

Today, more calls for changes in the way the Food and Drug Administration oversees drug safety. Last month, it was the well regarded Institute of Medicine, now it's the New England Journal of Medicine and a group of advisors to the FDA.

NPR's Joanne Silberner looks at the potential for change to the drug approval process.

JOANNE SILBERNER: A new conclusion of major problems with the FDA comes from five current or former members of an FDA safety advisory committee. In an article in the current Archives of Internal Medicine, they say the current drug approval process has problems from start to finish, starting with the inability to determine the safety of a drug before it's on the market, ending with an inability to recognize problems after a drug is widely available. Small fixes won't do, says one of the authors, Brian Strom of the University of Pennsylvania.

Dr. BRIAN STROM (University of Pennsylvania): The problem is FDA has the wrong structure, does not have the right authority, does not have sufficient resources to be able to do its job. And there are issues at FDA. I don't mean to say it's perfect, but the central issues are issues that require legislation.

SILBERNER: So the group made five recommendations for more legal authority to go after drug companies, more money to monitor drugs, more emphasis on drug safety, more independence for the advisory committees and the ability to give a new drug temporary approval pending further study.

Dr. STROM: Conditional approval process would restrict the companies and would change the labels so that the public is warned this is a new drug. There are as yet unknown side effects and you need to take that into account before you use it.

SILBERNER: The recommendations aren't all that different from a set issued by the Institute of Medicine last month, endorsed today by the editors of the New England Journal of Medicine as a crucial starting point. And there's at least support for a forum on Capitol Hill. Earlier this year, Republican Chuck Grassley of Iowa introduced legislation that would require the agency to review drugs after they're on the market. Grassley is getting a little impatient.

Senator CHUCK GRASSLEY (Republican, Iowa): Without a doubt, change is needed.

SILBERNER: Grassley suspects that with the critical reports from the Institute of Medicine and the FDA advisors, something will happen in the next Congress.

Senator GRASSLEY: Congress is going to not want to be seen as abdicating its responsibility on drug safety to the American people. More so, you know, it's our constitutional responsibility of oversight to see that an agency we set up, the Food and Drug Administration, is doing what it does.

SILBERNER: Former Senate staffer Sheila Burke, one of the co-authors of the Institute of Medicine report, also thinks something will happen soon.

Ms. SHEILA BURKE (FDA Panel Member): Next year, you have the renewal or the reauthorization of the legislation that essentially funds a great deal of the activity at the FDA, which will provide a natural opportunity for these issues to be engaged.

SILBERNER: The acting FDA commissioner has indicated that he's open to change, but if the recent past is any indication, any Congressionally mandated changes would come after a long and bitter fight. A vote on making the acting commissioner permanent, for example, is caught up in issues of importing drugs from Canada and the availability of an abortion drug. Political fights like that are why the Institute of Medicine report called for commissioners to have six-year tenures.

Joanne Silberner, NPR News, Washington.

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