Policy Update

July 23, 2012

We are fast approaching the close of another federal and state legislative session, and lawmakers at both levels are moving forward a number of MassBio’s policy initiatives.

Supreme Court upholds Affordable Care Act

On June 28, the Supreme Court of the United States upheld the federal Affordable Care Act, including the proposed pathway to biosimilars. MassBio will continue to work with the members of the Massachusetts delegation, as well as state and federal agencies to ensure that the law—when finally implemented in 2014—will positively impact patients who are in need of innovative therapies, many of which are made right here. Our focus will continue to be on ensuring federal policy protects innovation and guarantees patient access to the most cutting-edge treatments and cures.

PDUFA reauthorization secured through passage of Food and Drug Administration Safety and Innovation Act (FDASIA)

On July 9, President Barack Obama signed into law the Food and Drug Administration Safety and
Innovation Act (FDASIA), which included reauthoriziation of the Prescription Drug User Fee Act set to expire in September. We are pleased to report that FDASIA will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science, and strengthened post-market review. It will also increase the Food and Drug Administration's (FDA) access to external expertise to improve the drug review process. The enhanced Accelerated Approval pathway will help expedite the development of personalized therapies for patients suffering from serious and lifethreatening diseases while preserving the FDA's robust standards for safety and effectiveness.


Final budget includes co-pay assistance and partial repeal of gift ban

On July 8, Gov. Deval Patrick signed into law the Fiscal Year 2013 budget, which includes language that allows Mass. residents to take advantage of co-payment assistance programs. Until now, Massachusetts was the only state in the national that banned these programs. The budget also included langage to allow certain interactions between companies and physicians that had been barred under the “gift ban” previously enacted. “Gov. Patrick has, once again, demonstrated his commitment to an industry that is vital to the future of our state’s economy, but more importantly to the patients both near and far who await the next breakthrough therapies that will improve their lives,” said Geoff McKay, President & CEO of Organogenesis Inc. and Chairman of the Board at MassBio. “Any questions about Massachusetts’ pre-eminence in our industry were answered in the final version of the budget, which was thoughtfully prepared by Speaker DeLeo, Senate President Murray, and their dedicated members, and strikes a true balance between bolstering innovation and minimizing barriers to patient access.”



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