By Donald Zuhn --
It appears that Representative Henry Waxman (D-CA) (at right) will be the first to introduce a follow-on biologics bill in the 111th Congress. According to a Reuters report, Rep. Waxman has initiated a bipartisan effort to create a follow-on biologics regulatory pathway in the United States. Rep. Waxman, who was joined by Rep. Nathan Deal (R-GA), Rep. Frank Pallone (D-NJ) and Rep. Jo Ann Emerson (R-MO), called this effort one of his highest priorities this year.
As we reported previously, five follow-on biologics were introduced in the 110th Congress:
• "The Patient Protection and Innovative Biologic Medicines Act of 2007" (H.R. 1956), introduced by Congressman Jay Inslee in April 2007;
• "The Biologics Price Competition and Innovation Act of 2007" (S. 1695), introduced by Senator Edward Kennedy in June 2007; and
• "The Pathway for Biosimilars Act" (H.R. 5629), introduced by Congresswoman Anna Eshoo and Congressman Joseph Barton in March 2008.
Much of the debate surrounding these prior bills centered on the exclusivity periods provided by each bill, with H.R. 1956 providing twelve years of data exclusivity (the period of time during which a potential generic drug supplier is prevented from using an innovator's clinical trial and related data to substantiate the safety of the generic's medically equivalent drug) followed by two years of approval or market exclusivity (the period of time during which a generic drug supplier can file for, but not receive, FDA approval), S. 1695 and H.R. 5629 providing four years of data exclusivity followed by eight years of approval exclusivity, and S. 623 and H.R. 1038 providing the same exclusivity period found in the Hatch-Waxman Act (i.e., five years of market exclusivity for original products and three years for some modified versions of existing drugs).
Rep. Waxman's new bill (H.R. 1427; the Promoting Innovation and Access to Life Saving Medicines Act) reportedly provides the same exclusivity period set forth in S. 623 (the text of H.R. 1427 is not yet available on THOMAS). The Congressman said the new bill "will lead to healthy competition and long-term savings for patients and payers, and will preserve innovation in the biotech marketplace," adding that its approach was consistent with President Obama's proposal for creating a follow-on biologics regulatory pathway.
One analyst called Rep. Waxman's new bill "more pro-generic" than his previous effort, but believed the new bill would be "more balanced" following House debate on the exclusivity period (see Reuters report). The possibility that H.R. 1427 may lack "balance" should come as little surprise following the Congressman's remarks to the Generic Pharmaceutical Association (GPhA) last month. Addressing the issue of exclusivity, Rep. Waxman told the GPhA that "[t]he brand industry is calling for 12, 14, 16, and even 20 years of exclusivity," adding that "[i]t makes my head spin trying to keep up with [the brands'] ever changing arguments for why these terms are justified."
It did not take long for proponents and opponents of H.R. 1427 to issue statements regarding the new bill. GPhA President and CEO Kathleen Jaeger applauded Waxman's efforts in introducing a "consensus bill that achieves the balance of fostering pharmaceutical innovation while also making affordable medicines available to consumers" (see GPhA press release). Ms. Jaeger contended that in strengthening the U.S. health care system, "our priority must be to reduce costs while increasing access to quality care," adding that "[n]ow, more than ever, it's time to put patients first."
The U.S. subsidiary of Teva Pharmaceutical Industries Ltd., one of the largest generic pharmaceutical companies in the world, joined the GPhA in applauding the introduction of H.R. 1427 (see Teva press release). William Marth, President and CEO of Teva North America, stated that the new bill "can provide a vast benefit for all Americans and save billions at the same time." The Teva release noted that the average daily cost of a biologic drug is approximately 22 times greater than a traditional, small molecule drug.
The Biotechnology Industry Oragnization (BIO) took a different view of H.R. 1427. In a statement entitled "New Proposed Biosimilars Pathway Filled With Potholes," BIO President and CEO Jim Greenwood asserted that the Waxman bill "would take patients and our industry down the wrong path -- a path that jeopardizes the continued development of new breakthrough therapies and potential cures for debilitating diseases such as multiple sclerosis, HIV/AIDS and Alzheimer's," and argued that the bill "sets a path that jeopardizes our ability to help meet President Obama's call for a cure to cancer 'within our time' and help realize the promise of stem cell research." While Mr. Greenwood noted that BIO continued to strongly support the creation of a follow-on biologics regulatory pathway, he said that H.R. 1427 "seeks to cut prices but instead cuts corners." Interestingly, Mr. Greenwood did not directly attack the new bill's exclusivity period (BIO has previously indicated support for an exclusivity period of between 12 and 14 years). Instead, the BIO release focused on the bill's shortcomings with respect to safeguarding patient safety.
Patent Docs will have more on H.R. 1427 when the text of the bill has been made available.
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