Thursday, March 26, 2009

Haddad the Harbinger: Waxman-Hatch Activist Creates Company for Biogenerics

The robin is the traditional harbinger of spring. Here’s a harbinger of changes in the biologics business. The intense focus, activity and interest of one man in generics has been a reliable sign of big changes in the past and maybe again in 2009.

Bill Haddad, occasionally described as the “godfather” of the generics industry, is getting ready for follow-on biologics. He has established a self-funded company, Biogenerics Inc., in anticipation of Congressional action to create a pathway to approve follow-on biologics. His goal: once Congress acts, he will partner with FDA-approved plants overseas to expedite the entry of generic versions of off-patent biologics into the U.S.

Haddad has worked on the transnational movement of generics and biogenerics previously. He worked on biogenerics with Russian producers before starting his own company. Now, he says, companies in India are among the best candidates to produce biogenerics for the U.S. market, although he also cites developing industries in China, Australia and Korea. He currently acts as a U.S. representative for the Indian generics firm, Cipla, based in Mumbai.

Haddad says he has put together a list of products whose patents have expired as prime candidates for introduction to the U.S. biogenerics market – although he won’t discuss which ones with us -- and he has an idea of which firms he’d like to partner with. He’s also surveyed the range of products susceptible to patent challenges.

Another thing he’d like to do once the FOB regulatory pathway is created is to form a new trade association for biogeneric manufacturers – he was a founder of one of the original generic drug trade associations, so certainly knows how it’s done.

Haddad, a former journalist and Capitol Hill aide from the 1960’s, was a prominent voice pushing for expansion of the chemical generic industry in the 1970’s. His efforts led eventually to the1984 Drug Price Competition and Patent Restoration Act (Waxman-Hatch). He was one of the representatives for the generic industry in those discussions working with Waxman’s staffer Bill Corr (who is now headed to be Deputy Secretary of Health & Human Services).

Haddad’s connections to the expansion of low-priced drug competition goes way back. He represents one of the few people still active in the industry with ties back to the start of the Congressional effort to reduce intellectual property protections for the drug industry. At the beginning of his career, he was an aide to Tennessee Democratic Senator Estes Kefauver, for whom the 1962 drug efficacy amendments are named (“The Kefauver Amendments”). That major expansion of FDA approval authority actually arose out of efforts by Kefauver to cut back drug patent protections. That effort got side-tracked to enhanced safety and efficacy requirements by the thalidomide teratogenic experience in 1962.

Haddad smells another legislative milestone coming for generics in follow-ons and is giving Waxman’s current version of FOB legislation a good chance of clearing Congress. (See a summary of the provisions in Waxman’s bill by “The Pink Sheet” here). He called the bill “doable,” although he recognizes there is a lot of dealing left around data exclusivity and clinical trials. Until that approval pathway is set up, Biogenerics Inc. is “in a holding pattern,” he said.

As a business, Haddad sees a lot of potential for biogenerics, which he says any firm needs to be involved in in the next few years. If you’re just in small molecule drugs, “you’ll just be a commodity,” he said.

1 comment:

Anonymous said...

Will Sen Grassley be investigating all these connections of Haddad/Waxman? Will Sharfstein have to excuse himself from FDA dealing with biogenerics since he shares similar connections? With all these biogeneric plants overseas will there be continued calls to limit obtaining products from such sources?

Haddad may be correct that Small molecules drugs will soon just be "commodities" with the generic companies not investing in new R&D and draining funds from innovator companies. Weaking IP (biologics and small molecules) amounts to shooting the Golden Goose as soon will be no more eggs to copy.