In U.S., Domes Burn While FDA Fiddles

While balding men in 36 countries can legally obtain the world’s first clinically proven treatment for baldness, regulatory delays have left American males to deal with the fallout on their own.

When a panel of experts to the Food and Drug Administration recommended final agency approval of the eagerly awaited drug more than a year ago, industry analysts predicted swift action by federal regulators.

However, FDA officials say the drug is still under review with no immediate prospects of final agency clearance.

The drug is called Regaine--though it is to be marketed in this country under the name Rogaine--and it can be bought with just a doctor’s OK in Canada, Belgium and the United Kingdom, among others.

But not in the United States.

“It’s still under review,” an FDA spokesman said of Rogaine on Tuesday. The spokesman would not elaborate, but an agency source said the drug was “going nowhere fast.”

The drug, whose chemical name is minoxidil, works by being applied to the skin on the head where hair used to grow.

When Rogaine is approved, it will be the first baldness drug to gain a government endorsement.

Market analysts predict that it could end up as one of the largest selling drugs ever though it has been found in laboratory tests to have only a limited effect and to pose some risks of serious side effects in some patients.

It has been advancing through the FDA’s bureaucratic process at a snail’s pace though its arrival there coincided with an intense agency program to speed up the regulatory process.

Agency officials say there is no doubt that Rogaine ultimately will be approved.

Monitor for Side Effects

But it has been more than two years since the drug’s maker, Upjohn Co., filed for marketing clearance.

And it has been just over a year since the FDA’s own expert panel on dermatologic drugs recommended approval.

The advisory committee acted after FDA staff reviews concluded that Rogaine was sufficiently safe and effective against male baldness to comply with federal requirements.

The committee hedged its recommendation with several cautionary statements. It found that Rogaine’s effect was limited and that it also holds some risks, particularly for individuals with heart disease.

The panel recommended that the FDA let Rogaine go on sale only if its maker cautioned in packaging materials that patients be monitored for side effects such as irregular heart beat, changes in the heart rate, heart palpitations and fluid retention in the body while taking the drug.

Committee members predicted that after a year’s use of the drug--at an estimated cost of several hundred dollars--only about one in five men would see substantial results.

Though not binding on the agency, the views of the FDA’s expert committees typically carry great weight with officials.

Minoxidil has already been approved by the FDA when taken orally as a high blood pressure drug.

But Upjohn is required by law to seek separate approval for its use as a baldness treatment when applied to the skin.

Some FDA advisers conclude that the FDA has purposefully kept the baldness drug on a slow track toward approval, believing that drugs for such conditions as AIDS, heart disease and cancer should be treated with more urgency.

“It’s seen as a low priority since it doesn’t save lives or cure a serious illness,” said a private research physician who advises the agency on skin disease treatments.