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A much-anticipated Federal Trade Commission (FTC) report was released on Wednesday that will likely help House Energy and Commerce Chairman Henry Waxman bolster support for his fledgling follow-on biologics (FOB) bill. For those of you who haven’t been closely following the debate over proposed legislation to create a regulatory framework for approval of FOBs in the US, I provide a brief synopsis.

The Promoting Innovation and Access to Life-Saving Medicines Act (H.R.1427) introduced by US Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ) and Nathan Deal (R-GA) calls for an abbreviated development pathway (at the discretion of the agency), the possibility of substitution or interchangeability (if the follow-on biologics manufacturer can prove a high degree of structurally similarity and an identical mode of action) and five years of data exclusivity. In contrast, The Pathways for Biosimilar Act (H.R. 1548) introduced by US Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA) and Joe Barton(R-TX) requires clinical data, rigorous immunogenicity testing and limits on interchangeability and substitution provisions for follow-on biologics. Further, it calls for a minimum of 12 or up to 14 years of data exclusivity for innovator companies—a period during which FDA can’t rely on innovator data to approve follow-on biologics. For example, if a biotechnology drug was approved in 2009, the earliest that FDA could consider and approve an application for a competing follow-on product is 2021.

The FTC report concluded that a 12- to 14-year wait is unnecessary because follow-on biologics will not be offered at the same steep discounts as traditional generic drugs. It also pointed out that no evidence exists that biologic patents will not hold up. The agency estimates follow-on biologics would be sold at discounts ranging from 10 percent to 30 percent. Not surprisingly, the FTC did not recommend a specific number of exclusivity years. This allows legislators to continue to squabble and debate the point ad nauseum, until concessions are made by both innovator and follow-on biologics proponents.

The measure by Eshoo and Barton has garnered 88 co-sponsors, while Waxman and Deal's bill has 11. In the Senate, the Health, Education, Labor and Pensions Committee reached a bipartisan compromise on follow-on biologics in 2007 that allowed for 12 years of exclusivity, but that deal seems unlikely. Democrats are trying to address generic firms' concerns that brand companies could make slight changes to their products and start the exclusivity period over again. Some senators introduced a more generic-friendly bill like Waxman's earlier this year.

Conventional wisdom suggests that the data exclusivity provisions in the final legislation will be five years—a period identical to that provided stipulated in the 1984 Hatch Waxman Act, which created the US generic pharmaceutical industry. 

Stay tuned for new updates on this unfolding drama!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!! 

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Things are not going well these days for Wyeth or the US Food and Drug Administration. In the latest of a series of complaints over FDA's safety review of drugs and industry influence on the agency, a Senate panel found flaws in its scientific objectivity when it reassigned an agency veterinarian over unfounded conflict –of- interest accusations by Wyeth.

The congressional inquiry looked into how the FDA dealt with Wyeth’s accusations against Dr. Victoria Hampshire, an FDA regulator who was helping to review the safety of one of Wyeth’s lucrative veterinary drugs. The case centers on Proheart 6, an injected dog heartworm medication that Wyeth pulled from the market in September 2004 after Hampshire linked the drug to dog deaths. Wyeth later complained about alleged bias by Hampshire. The company claimed that she intend to sell competing drugs through her own Web site. After Wyeth made the allegations, Hampshire was abruptly reassigned to another job within FDA and her case was referred to the U.S. attorney's office for possible criminal prosecution. Federal prosecutors quickly dropped the case, and much to FDA’s chagrin, in 2006, the U.S. Public Health Service named Hampshire veterinarian of the year.

Congressional investigators discovered that FDA referred Hampshire's case to prosecutors on the basis of mistaken allegations about her Web site that could easily have been checked but were not. As it turned out, Hampshire’s did little business at her website and did not sell any products that competed with Proheart 6. In fact, she actually sold Wyeth’s Proheart 6 until the company pulled it from the market. Go figure….

In a letter to HHS Secretary Michael Leavitt and FDA Commissioner Dr. Andrew von Eschenbach, panel Chairman Senator Charles Grassley (R-Iowa) wrote that the panel’s findings suggest “that the scientific process is being compromised internally" at the FDA. Also, he wrote that the case brings into question "the processes that FDA uses in response to industry allegations of wrongdoing by FDA employees."

FYI, a FDA advisory panel narrowly voted to keep Proheart 6 off the market shortly after Hampshire was reassigned in 2004.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

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