Follow-On Biologics Theatre: Next Act Is FDA

A House subcommittee hearing on FTC’s report on FOB competition includes yelling, a “challenge” to take an FOB product – and a promise from Chairman Pallone for more of the same.

When faced with unpleasant news, people often try to change the subject or even pretend the thing didn't happen. Both of those coping strategies were on display during a June 11 hearing on biologics competition by the House Energy and Commerce Committee's Health Subcommittee.

The day after the Federal Trade Commission released its report on follow-on biologics, the hearing allowed members the opportunity to question Commissioner Pamela Jones Harbour about the findings and to hone their arguments in response.

¹ FTC's report concluded that because the follow-on biologics market will best resemble brand-to-brand competition, neither extensive innovator exclusivity nor any FOB exclusivity is necessary to ensure price competition and product discovery (² (Also see "FTC’s Low Blow On FOBs" - Pink Sheet, 10 Jun, 2009.)).

The generics camp has essentially taken this news lying down. The Generic Pharmaceutical Association's statement in response to the report doesn't mention the issue, and no legislator asked about FOB exclusivity at the hearing.

The generics industry and its allies seem so satisfied with the primary conclusion of FTC's report - which deems the major economic study supporting the brand argument for lengthy exclusivity "imprecise and non-robust" - that it appears they would rather live with some of the less agreeable elements of the report than in any way weaken the anti-brand conclusions they find so valuable.

Brand manufacturers and their supporters, on the other hand, challenged the report's rigor and underlying assumptions and often tried to shift the focus of the hearing to product safety rather and marketplace competitions.

FDA will be key player in the debate

"Why are we seeking the counsel of the Federal Trade Commission on a issue where we are most concern with regard to the drug's safety and efficacy?" Rep. Steve Buyer, R-Ind., asked. During the witness question period, Buyer and Harbour had a testy, high-volume exchange, with Buyer at one point noting he was "not asking" her a question.

Subcommittee Chairman Frank Pallone, D-N.J., said the panel would hold additional hearings that would include FDA and address product safety issues. That pledge - along with the fact that some of the most strident critiques of FTC's report came from the Democratic side of the aisle -illustrate the challenges proponents of an FOB approval mechanism will have if they hope to include the pathway in health reform legislation expected to be developed this summer.

Full committee Chairman Henry Waxman, D-Calif., has moved to accelerate the adoption of a pathway by urging the Obama administration to act on its own to approve follow-on biologics (³ (Also see "FOBs Help Wanted: Waxman Appeals To Obama" - Pink Sheet, 8 Jun, 2009.)).

Rep. Anna Eshoo, D-Calif., who is sponsoring legislation that is more brand friendly than the bill from Pallone and Waxman, also pressed the issue of follow-on biologics safety at the hearing. "I would challenge you to ingest what comes out" as a result of FOB policy, she said to Harbour.

Eshoo also wrangled with Pallone about submitting into the record a letter written by FDA's then Chief Medical Officer Frank Torti that raised serious questions about the approvability of follow-on biologics.

"These are the ones from the previous administration?" Pallone asked. "We've asked them again in the current administration."

If FDA produces a new letter - or congressional testimony - that is more supportive of an FOB approval pathway than the ⁴ Torti letter, it will clearly help Pallone's cause. But those findings will face the challenge of having to explain why they may contradict previous formal agency statements (⁵ (Also see "FDA Follow-On Biologics Letter Creates Hurdle For Obama Administration" - Pink Sheet, 19 Jan, 2009.), p. 7).

-M. Nielsen Hobbs ([email protected])