Biotech Values

[DewDiligence]

Another area ripe for generic-drug reform:

[Perhaps I should have added Mylan’s beef to my wish list of policy changes in #msg-3443385.]

http://biz.yahoo.com/rc/040630/health_mylan_2.html

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Mylan demands FDA respond to 'citizens petition'

NEW YORK, June 30 (Reuters) - Mylan Laboratories Inc. (NYSE:MYL - News) said on Wednesday it had supplemented a previously filed petition to U.S. regulators, calling for an immediate response to Mylan's claim that branded drugmakers are unfairly undermining sales of generic drugmakers.

Mylan submitted a so-called "citizens petition," in February, demanding the agency prevent top drug companies from marketing their branded drugs as so-called "authorized generics."

When the patent ends on a brand name drug, the first generic drugmaker that is approved for a cheaper, chemically equivalent version by the Food and Drug Administration traditionally receives an exclusive period of 180 days before other generic companies are allowed to sell their cheaper versions of the branded drug.

Major drugmakers are circumventing that exclusivity period by cutting deals with other generic companies to sell cheaper versions of their own drugs -- so-called authorized generics -- while they also continue selling the expensive branded versions, according to accusations by Mylan.

"The damage to us through lost market opportunity, as well as to the generic industry and ultimately consumers who rely on generics to contain healthcare cost, makes this an issue that deserves to be addressed," said Mylan chief executive Robert Coury.

In March, Mylan sued Procter & Gamble (NYSE:PG - News) and Watson Pharmaceuticals (NYSE:WPI - News) , charging that a deal between the two that allowed Watson to sell a generic version of Procter & Gamble's urinary tract infection drug Macrobid during Mylan's 180-day exclusivity period violated the law.

Mylan said the practice of a branded company "authorizing" a generic version of its own drug is misleading to consumers and harmful to generic companies that have won FDA approval.

In its petition, Pittsburgh-based Mylan requested that the FDA "prohibit the marketing and distribution of 'authorized generic' versions of brand name drugs until the expiration of the first generic applicant's 180-day exclusivity period."

Coury said Mylan expects the issue will ultimately be resolved in court.
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