Congress is busy doing what it does best. That is, taking a massive, overly-convoluted piece of legislation and making it more complex with amendments. And so it is with the “America’s Affordable Health Choices Act of 2009” bill (H.R. 3200, 1018 pages and counting). After adding in hundreds of amendments that never seem thoughtfully considered […]

“To amend the public health service act to establish a pathway for the licensure of biosimilar biologic products, to promote innovation in the life sciences.” Amendment No. 297. The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted Monday in favor of a proposal by Sens. Kay Hagan (D-NC), Michael Enzi (R-WY), and Orrin […]

The Obama Administration sent out a warning shot that seven years is enough time to protect brand-name biotechnology medicines from generic competitors.  In a letter to Representative Henry Waxman (D-CA), the White House set out that seven years “strikes the appropriate balance between innovation and competition by providing for seven years of exclusivity.” In looking […]

Deloitte has released a study, Avoiding no man’s land: Potential unintended consequences of follow-on biologics, that explores the debate on creating a regulatory pathway for the approval of follow-on biologics (FOBs, the biotech equivalent of generic pharmaceuticals). The study also outlines unintended effects of the Hatch-Waxman Act of 1984 and compares it with current proposed […]

The full text of the Pathway for Biosimilars Act (H.R. 1548) introduced in the House has now been released.  The Act is set to amend the Public Health Service Act in order to establish a pathway for the licensure of biosimilar biological products, and for other purposes. The Act provides for the following: EXCLUSIVITY FOR […]

Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R- TX) have introduced the Pathway for Biosimilars Act (H.R. 1548).  The key provision of the Eshoo-Inslee-Barton bill is the 14-year data protection period.  It would offer all new biological drugs a base period of 12 years of data protection with the right to obtain […]

Reps. Henry A. Waxman, Frank Pallone, Nathan Deal, and Jo Ann Emerson are giving another try at getting a pathway set for follow-on biologics.  They have introduced H.R. 1427, the “Promoting Innovation and Access to Life-Saving Medicine Act,” a bipartisan bill to allow the Food and Drug Administration to approve generic copies of biotech drugs.  […]

The Biotechnology Industry Organization (BIO) held a press conference today to provide an overview of the federal policy landscape and impact of the current financial market environment on the biotech industry. BIO President and CEO Jim Greenwood addressed the policies expected to be considered by the Obama Administration and the 111th Congress which will impact […]