By Donald Zuhn --
Presidential Candidates Support Follow-on Biologics Regulatory Pathway
Last week, Forbes.com reported that representatives of Senator Barack Obama's and Senator John McCain's campaigns have indicated that each candidate, if elected, would place the passage of a follow-on biologics regulatory pathway at the top of his health care agenda.
The primary sticking point in securing passage of a follow-on biologics bill remains the length of time that innovators would enjoy market exclusivity. As Patent Docs reported last March, the Biotechnology Industry Organization (BIO), echoing the sentiments of innovators, supports a 14-year period of exclusivity (see "New Follow-on Biologics Bill Introduced in the House"). Generic drug manufacturers, on the other hand, have been pushing for a 5-year period of exclusivity (as evidenced by a Teva-funded report on market exclusivity that was released last week; see "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation"). According to the Forbes.com report, McCain campaign adviser Douglas Holtz-Eakin stated that "Senator McCain's instincts are to make the [exclusivity] period as short as possible so that you 
can get products to market more quickly." Forbes.com also noted that Obama similarly supported making the exclusivity period as short as possible for biotech drugs. In addition, Obama's health care advisor Dora Hughes noted that the Illinois Senator intends to put an end to the "reverse payment" practice, in which innovators pay generic drug manufacturers to delay introduction of generic drugs.
Interestingly, Forbes.com also reported that an analyst with Lehman Brothers has predicted that Congress will pass follow-on biologics legislation by 2010, and that such legislation will include a compromise on market exclusivity of 10 years.
[Update: The Pharmaceutical Business Review has also filed a report on the presidential candidates' positions regarding a follow-on biologics regulatory pathway.]
Congressman Waxman Says Biotechs Enjoy "Superpatents"
BioWorld reported today on comments Representative Henry Waxman (D-CA) made at a forum at George Washington University on Monday. Congressman Waxman, whose name is associated with landmark legislation that created a regulatory pathway for chemical therapeutics (i.e., the Hatch-Waxman Act, formally known as the Drug Price Competition and Patent Term Restoration Act of 1984), declared that biotechnology companies "enjoy a monopoly" giving them "something like a superpatent" as a result of the absence of a follow-on biologics regulatory pathway. According to the BioWorld report, Congressman Waxman stated that "[u]ntil and unless we in Congress act to give the FDA authority to approve generic biologics, the biotech industry will continue to enjoy these permanent monopolies, and employers, insurers and the federal government will continue to pay the staggering monopoly prices we have today." Not surprisingly (since he has introduced a follow-on biologics bill of his own, H.R. 1038, that parallels the Hatch-Waxman Act), Congressman Waxman found the exclusivity periods specified in three other follow-on biologics bills to be too long (see "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation"). In particular, BioWorld noted that the Congressman argued that "[t]he periods of some of those generic biologic legislative proposals are so long that they are not just unbalanced, they totally transform the legislation into huge giveaways that replace adequate incentives with windfall profits."
IPO Passes Resolution on Biosimilars
The Intellectual Property Owners Association (IPO), which just concluded its 2008 Annual Meeting in San Diego, announced today that among the resolutions the IPO Board adopted on Sunday was one addressing biosimilar legislation. The resolution reads:
RESOLVED, IPO supports, in principle, legislation that would allow approval of a biological product as biosimilar to a reference biological product which:
(1) ensures patient safety by granting the FDA authority to approve biosimilars using a scientifically-based, case-by-case approach;
(2) promotes continued innovation by providing at least 14 years of data exclusivity for an innovator’s biological product with additional periods of exclusivity available for new indications and/or for approval for use in the pediatric population; and
(3) encourages efficient clarification of intellectual property issues by allowing confidential access to information reasonably relating to the infringement of any patents, including manufacturing and product information, and mechanisms for enforcing the confidential access requirement.
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