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FDA Soft Sells Bad News To Drug Makers

Posted by Jane Akre
Thursday, July 10, 2008 11:58 AM EST
Category: Major Medical, Protecting Your Family
Tags: FDA and Prescription Drugs, Drug Products, Drug Approvals, Dangerous Drugs

FDA is revising the way it sends letters to drug companies concerning new submissions.




In what appears to be an abundance of sensitivity toward issuing any bad news about a new drug application  - the FDA is revising the letter it sends to drug makers.  

A new drug, submitted for approval, had previously generated one of three different types of letters from the FDA.

An “approved” letter meant that it could be marketed for sale in the U.S.; an “approvable” letter, meant approval will come at a later date provided the applicant adds certain information or makes specified changes; or a “not approvable” letter, meant the application had deficiencies and had to have additional data submitted.

Now, the FDA’s Center for Drug Evaluation and Research (CDER) will send what it calls “complete response letters” - relaying the status of a drug approval in a more neutral way.  The changes take place next month.

The move avoids scaring off investors, the agency says in a 122-page overview of the new policy on its web site. 

“In the past, some drug manufacturers expressed concern that a not-approvable letter sent an unintended message that a marketing application would never be approved, which could adversely affect a company’s ability to raise capital.”

The FDA is reportedly already using the new format concerning drugs produced through biotechnology – an area of drug production that relies on attracting new investors.

Not just a turn down, the FDA letters will inform a drug maker how to fix the problems holding up approval. But don’t expect to learn any more. These letters are not available to the public.

As far as information available to prospective investors, Jon LeCroy, a pharmaceutical analyst, tells the New York Times that investors may actually be less informed by these response letters then they were from a strict approved or not approved letter.

Mr. LeCroy said in a note Wednesday to clients. “Investors will no longer know whether a drug is dead in the eyes of the F.D.A.”

It will be up to management to honestly relay to investors what the letters contain.

In the past, the agency had to work within 180 days to give its assessment of a drug.  Now the new rules may extend that time, especially if a company files an amendment to an application. #

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