12 Years of Data Exclusivity for Biologics?
|July 14, 2009
Late last night the Senate Health committee voted 16 to 7 in favor of a proposal for 12-years of data exclusivity for brand-name biologics that was offered by Sens. Mike Enzi (R), Orrin Hatch (R-UT) and Kay Hagan (D-NC). This proposal was backed primarily by the brand-name biotech and pharmaceutical industry and opposed by consumer groups, a large group of state legislators, unions, several large employers, pharmaceutical benefit management firms, and generic drug companies. I believe but am unsure that the up to 14-years data exclusivity proposal is identical to what was offered in the Kennedy/Clinton/Hatch bill (S. 1695) passed in the committee in the 110th Congress in 2007, but the text has not yet been made available as of the writing of this post, so details are unclear. The FDA approval pathway is said to be almost identical to whatwas in S. 1695 as well. The Enzi, Hatch and Hagan proposal also added a four year filing moratorium for generic applications (from the date of FDA approval). The exclusivity period in the bill will apply to all biologics passed under the Public Health Services Act starting from their date of FDA approval.
By a 5 to 17 vote the committee rejected an alternate measure backed by consumer groups that was proposed by Sen. Sherrod Brown (D-Ohio). This proposal would have started with a seven-year data exclusivity period, with a limited amount of additional years possible for innovations that require additional clinical trials, and no filing moratorium on generic applications.
The Enzi-Hatch-Hagan proposal was added to the current health care reform bill that the Senate Health committee is close to finalizing. Senator Dodd believes the markup of the bill (which has yet to be officially introduced) can be finalized today or tomorrow. Next the Senate Finance Committee will work on its own version of a bill and then Senate leadership will combine the two bills into one. The full Senate will have a chance to vote on the bill after these processes are finished. It is currently believed there will be a chance to alter and improve the biologics provisions by floor amendment, if it is not or cannot be done in the Finance Committee or by leadership before then.
In the meantime, the House Committee on Energy and Commerce has not yet finalized its version of a biogenerics bill, which will probably be added to its health care reform proposal as well.
Initially the two competing house bills were being considered separately from the health care reform act, but there is a large group of representatives pushing for a brand-name industry-backed bill -- H.R. 1548 introduced by Representatives Anna Eshoo (D-CA) and Joe Barton (R-TX)-- to be folded into the house health care reform bill. This bill, which offers up to 14.5 years of data exclusivity, is very similar to the Enzi-Hatch-Hagan Senate proposal. In light of the activities in the senate, and in light of the fact the Rep. Eshoo's bill by her own admission likely has the votes to force its incorporation into the broader health bill, U.S. Congress is coming dangerously close to enacting a bill that will work against their overarching objective of making health care affordable for all Americans.
Energy and Commerce Chairman Henry Waxman (D-CA) and Ranking Member Nathan Deal (R-GA) are backing a competing bill (H.R. 1427) that offers a base of 5 years of data exclusivity. This bill is was endorsed by a large consumer, business, worker and industry coalition. The Obama Administration has recently indicated it supports a "generous compromise" of 7 years base period of exclusivity and that it rejects the call for 14 years.
Despite what has happened in the senate and the strong support so far for the brand-name industry-friendly Eshoo proposal in the house (131 co-sponsors to date), it is not too late to see a consumer-friendly bill passed. There is still time to build more support for the Waxman-Deal biogenerics proposal (H.R.1427) in the House Committee on Energy and Commerce before it votes on the Eshoo-Barton Proposal. Moreover, Congresspersons in both houses will have the opportunity to amend the biogenerics proposals for the better on the floor. We must work to ensure that happens.
For press coverage of the Senate proposal passage last night, see:
Photo of pills posted on flikr.com under a creative commons license by Darren Hester.