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Category Archives: Policy Corner

Senate HELP Committee Launches Drug Development Initiative

The Senate Health, Education, Labor, and Pensions Committee (HELP), under Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA), announced that it is launching a bipartisan initiative to examine the drug and device development and regulatory processes. The initiative will focus specifically on the National Institutes of Health (NIH) and U.S. Food and Drug Administration (FDA) and will commence with a bipartisan working group meeting in mid-February, followed by a series of hearings in March.

BayBio Thanks Commissioner Hamburg for Leadership

On February 6th, Margaret Hamburg, M.D., announced she will be resigning as Commissioner of the U.S. Food and Drug Administration (FDA) at the end of March, 2015. Commissioner Hamburg has been the head of FDA for nearly six years, and has overseen many developments and positive changes within the agency during that time.

Reintroduction of Innovation Act

Last week, U.S. House Judiciary Chairman Bob Goodlatte (R-VA) introduced H.R. 9, The Innovation Act, which is legislation that would significantly change patent litigation processes and procedures. H.R. 9 is almost identical to last year’s H.R. 3309, also titled The Innovation Act, which passed the House. The bill does not take into account the most recent patent litigation developments, including implementation of The American Invents Act, multiple Supreme Court decisions, and changes at the U.S. Patent and Trademark Office.

Senate Health Committee Convenes to Discuss Healthcare Cost Concerns

On February 4, the California Senate Health Committee held an informational hearing to discuss rising healthcare costs, with a particular focus on prescription drug pricing and the effect of hospital mergers on patient costs in the Golden State. The hearing focused on three constituent groups in the delivery of healthcare — payers, providers, and biopharmaceutical companies — and sought to discern the underlying causes of rising healthcare costs in California and across the country.

Marin County Explores Possible Drug Takeback Legislation

On January 30, RXSafe Marin, a cross-section of various county departments and community interest groups, held a Safe Medicine Disposal Forum at the Marin Health and Human Services Wellness Campus in San Rafael. The meeting, heavily influenced by the California Product Stewardship Council, focused on the legislative steps that Marin County should take in order to have a producer funded drug takeback program in place by June 2016.

House Energy & Commerce Committee Releases 21st Century Cures Discussion Draft

The House Energy and Commerce Committee released the 21st Century Cures Initiative discussion draft, which includes a broad range of proposals meant to help accelerate the discovery, development, and delivery of new treatments and cures. Since April of 2014, the House Energy and Commerce Committee, under the leadership of Chairman Fred Upton (R-MI) and Diana DeGette (D-CO), has held dozens of panels, roundtables, and hearings on the comprehensive biomedical innovation ecosystem. Key stakeholders, including patients, industry, researchers, regulators, providers and biomedical trade associations such as BayBio, have provided information and ideas to help shape the proposals put forth in this draft.