By Donald Zuhn --
Virginia Governor: Time Has Come to Move Forward
Virginia Governor Timothy Kaine, once a candidate to be President Obama's running mate, sent a letter to the Virginia Congressional delegation at the end of June, stating that he was "encouraged by efforts in Congress to strengthen the approval process for biogeneric and biosimilar products," and "strongly encourag[ed the delegation] to move forward with legislation this year." According to Gov. Kaine (at right), the most important goal of follow-on biologics legislation should be to "provide a competitive environment for biogeneric and biosimilar products that both rewards innovation and provides incentives for generic manufacturers." Gov. Kaine also asserted that "[t]he Food and Drug Administration is the appropriate authority to provide a reasonable and safe regulatory framework to accomplish this goal," since the FDA would be able to "use the same scientific process and the same discretion that it currently has to approve innovative biologics." He concluded his letter by stating that "[t]he time has come for Congress to move forward on this critical issue," noting that "[b]iogenerics and biosimilar products now are approved in countries around the world and it is time that we bring the benefits from these lower cost products to our citizens." The Virginia Governor did not, however, take a position on what has become the most contentious issue in the follow-on biologics debate: the length of the data exclusivity period.
CMPI Hosts Congressional Briefing on Follow-on Biologics
Last Wednesday, the Center for Medicine in the Public Interest (CMPI) hosted a briefing for Congressional staff to focus on patient safety as a top priority for follow-on biologics legislation. The briefing was co-hosted by Rep. Anna Eshoo (D-CA), who introduced follow-on biologics legislation (H.R. 1548) in the House that would provide up to 14.5 years of data exclusivity, and Rep. Mike Rogers (R-MI), one of 136 co-sponsors of Rep. Eshoo's bill. Rep. Eshoo and Rep. Rogers are members of the House Energy and Commerce Committee, which will determine the specific language of any follow-on biologics bill that makes it to the floor of the House for a vote. The Energy and Commerce Committee is Chaired by Rep. Henry Waxman (D-CA), who has introduced competing legislation (H.R. 1427) that currently enjoys the backing of 13 co-sponsors.
The CMPI, which describes itself as "a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered," applauded the commitment of Rep. Eshoo and Rep. Rogers for "ensuring [that] patient safety is the top-priority for follow-on biologics legislation." The CMPI stated that "[t]he next few weeks are going to be a pivotal time in Congress as health care takes top billing in the House and the Senate," adding that "[i]t is critical that advocates for safe and effective follow-on biologics do all they can to support Representative Eshoo's legislation."
Also speaking at the event were former Congressman Mike Ferguson; Dr. Geno Merli (at left), Senior Vice President & Chief Medical Officer at Thomas Jefferson University, and Director of the Jefferson Center for Vascular Diseases; and John Crowley, President and Chief Executive Officer of Amicus Therapeutics. Patent Docs touched base with Dr. Merli following the briefing. Dr. Merli discussed how differences in similar but not identical forms of the anticoagulant disirudin affect its ability to bind thrombin, thereby affecting its ability to prolong clotting time. Dr. Merli noted that Mr. Crowley's presentation similarly focused on the differences between a biologic and a biosimilar, and the ramifications such differences could have on patient safety. In Mr. Cowley's case, the biologic was an enzyme being developed by Amicus Therapeutics and the biosimilar was a similar version of the enzyme that was also developed by his company. Despite a high degree of similarity between the molecules, the biosimilar did not behave in the same manner as the biologic. Dr. Merli concluded the conversation by noting that he did not have a particular position on the length of a data exclusivity period, but that "there should be some amount of time" to reward an innovator for the time and money it invests in developing a biologic.
"Consumer Groups" Battle 12-Year Data Exclusivity Period
Last Thursday, the AARP, Consumers Union, and Coalition for a Competitive Pharmaceutical Market (CCPM) sent a letter to Rep. Waxman stating that "[i]n all frankness, we cannot be supportive of any generic biologics legislation that would be an empty promise to the Americans we represent and serve." According to a report on CNNMoney.com, the three groups were threatening to pull support for any follow-on biologics legislation that would provide 12 years of data exclusivity, arguing that "no bill is better than a bad bill." Interestingly, the "consumer groups" letter was also signed by the Generic Pharmaceutical Association (GPhA). Also of interest is the way the CCPM described its group in a December 8, 2008 letter to the Obama-Biden Transition Project: as "an organization of large national employers, health plans, PBM's, chain pharmacies, generic drug manufacturers, biopharmaceutical companies and others representing more than 200 million beneficiaries." The letter also urged members of Congress to "reject the fatally flawed" bill introduced by Rep. Eshoo in March, and criticized the bill passed by the Senate Senate Health, Education, Labor and Pensions (HELP) Committee last week. The signatories said they would "outright oppose" any legislation providing 12 years of data exclusivity, and that such legislation would "serve as little more than a cruel hoax to some of our most vulnerable American citizens."
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