New drugs' OK process lengthy, costly

February 1, 2007

National report - The Food and Drug Administration's role is a necessary one, dermatologists say, but regulatory red tape can slow the introduction of new drugs into the marketplace, and post-marketing restrictions can hamper efforts to deliver effective medications to patients.

National report - The Food and Drug Administration's role is a necessary one, dermatologists say, but regulatory red tape can slow the introduction of new drugs into the marketplace, and post-marketing restrictions can hamper efforts to deliver effective medications to patients.

Process is challenging

Clear-cut regulations govern the march of a drug from the bench to the bedside.

The approval process can be "lengthy, cumbersome, expensive and sometimes unpredictable," says Alexa Boer Kimball, M.D., M.P.H., assistant professor of dermatology, Harvard Medical School, Boston, who performs small investigator-initiated FDA trials.

"It's not uncommon to see changes in terms of design requirements and safety review questions that neither I nor the sponsors would have predicted," she says.

The process becomes even more difficult, Dr. Kimball says, "if the people one has been working with change in midstream. It subjects the whole application to another level of review and interpretation."

But FDA officials say the agency works closely with pharmaceutical companies and has a good track record at meeting review deadlines.

"FDA and industry share a common goal - public health," says Susan Walker, M.D., director, FDA Division of Dermatology and Dental Products.

Dr. Walker says FDA's Center for Drug Evaluation and Research (CDER) works closely with drug manufacturers by offering meetings intended to speed the review process "so that the American people can benefit sooner from drugs that are safe and effective."

Unwelcome regulation?

Oversight continues even after a drug has reached the marketplace - and that has led to some recent FDA decisions that many dermatologists challenge.

Hotly debated is the federal iPLEDGE program, which placed cumbersome new restrictions on the availability of isotretinoin, a highly effective medication for patients with severe acne.

iPLEDGE is "a nightmare," Dr. Donsky says. "The doctor has many hoops to go through and problems to deal with. It's sort of like working for an HMO - there are so many disincentives to do something just because of the time and energy it takes that there's a tremendous temptation to do less than what's optimal for the patient."

Dermatologists also objected to the FDA's 2006 decision to add "black box" warnings to packaging for the drugs Elidel (pimecrolimus, Novartis) and Protopic (tacrolimus, Astellas/Fujisawa), prescribed for patients with moderate to severe atopic dermatitis. The warnings were prompted by reports of lymphomas and skin cancers associated with use of the topical medications.