FDA Policy Could Clear Up Acne Questions

Guidelines Could Pave Way For More Specific Drugs

From the WebMD Archives

Nov. 8, 2002 -- Treating acne is hard to do. There are a number of drugs out there, but studies have shown that doctors are unsure which work best for various patients.

That's in part because the FDA's current testing guidelines often don't reveal the specific patients that would most benefit from a drug's effects.

Now, an FDA advisory committee has recommended changes to those procedures, perhaps paving the way for more specific drugs.

The trouble comes because your average teen is afflicted predominantly with one of two forms: red, irritated inflammatory acne; or non-inflammatory acne, such as blackheads or whiteheads. But the current testing requirements are not designed to effectively distinguish treatment of the two, so doctors are left with shuttling from one prescription to the next, searching for the drug or combination that brings relief.

Under the recommended guidelines, it would be somewhat easier for drug companies to get a drug approved because they only have to show that their drug is effective against one type of acne or the other.

The committee's recommendations are non-binding, but the FDA usually accepts them.

If the FDA does indeed incorporate the changes, what will that mean for acne sufferers? Future medications will be more directly targeted to the type of acne, and doctors are more likely to get it right on the first try.

"We now better understand the disease, and we can direct therapy more specifically. ... I think it's going to provide for more appropriate prescribing," R. Todd Plott, MD, vice president of clinical research at acne drug maker Medicis, tells WebMD.

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