The biosimilars legislation which passed in June awaits the Governor's signature, but he has 45 days to sign it into law after the Assembly reconvenes. California and Puerto Rico also have bills awaiting their Governors' signatures, which brings the number of states that have either passed or have biosimilars legislation pending to 20.
Congress has a more robust life sciences agenda, but with Presidential contenders in the Senate looking to 2016, it's even less likely that there will be much action there. A potential government shutdown will dominate the early fall months, and possibly stop activity totally if the shutdown occurs, which could happen as early as the end of September.
At issue is the $18.1 trillion debt limit. Without Congressional approval of an increase in the government's borrowing authority, we will hit the limit in mid-November or early December, according to Congressional Budget Office (CBO) predictions. Unless approval is given to exceed the limit, the U. S. would be in default on the national debt (for the first time ever) and government would be forced to shut down.
It's unlikely that the default and ensuing shutdown will occur, but the debate will provide a platform for the 2016 Presidential and Senate races. With the Iran treaty, Planned Parenthood funding and additional Affordable Care Act (ACA) reform also in the mix, there is unlimited potential to stall debate on most other pending legislation.
In spite of this, the life sciences community is hopeful that action will be taken on several pressing issues:
21st Century Cures Act - Without Senate passage of the Innovation Act, the companion legislation to the sweeping 21st Century Cures Act, nothing can move forward. The House legislation will advance medical research and provide new medicines to patients faster. It also provides for increased NIH funding and enhanced patient involvement in the development of new medicines.
BioNJ is working with a coalition of trade associations and patient advocacy organizations to urge prompt Senate action on the Innovation Act, and we encourage our Members to contact New Jersey Senators Robert Menendez (www.menendez.senate.gov) and Cory Booker (www.booker.senate.gov) and urge them to support speedy review and passage. The Senate version of the bill will be heard in the Senate Health, Education, Labor and Pensions (HELP) Committee, chaired by Sen. Lamar Alexander (R-TN) with Ranking Member Patty Murray (D-WA).
Patent Reform - Debate over the Patent and Trademark Office's (PTO) process of Inter Partes Review (IPR) continued in the House until Congress convened for the summer recess. The life sciences industry is pressing for an exemption from IPR, which allows a lower burden of proof to invalidate patents than the standard used in district court, for biotechnology and pharmaceutical products. Resolution of the IPR issue is a major hurdle in both the House and Senate versions of the legislation.
BioNJ supports the exemption and is actively engaging in discussion with members of New Jersey's Congressional delegation.