Category Archives: Policy Briefs
Now that the March 1st deadline to avoid sequestration has passed, national focus has shifted to how Congress can avoid government shutdown at the end of the month. In the fiscal year 2013 alone, $85 billion in reductions are set to go into effect, and its impact will be felt in the coming weeks. If the impending cuts are enacted, the biotech community can expect to be affected in a number of ways.
Some of the largest sequester cuts will be to the National Institute of Health (NIH), which is the biggest funder of medical research in the U.S. The budget of the NIH is scheduled to drop 7.6 percent in the next five years, forcing the NIH to delay or halt vital scientific projects and make hundreds fewer research awards. These NIH cuts will disproportionately harm Massachusetts, as the Commonwealth receives twice the NIH funding per capita than other states. These cuts not only have the potential to devastate our state economy, but will also delay progress on preventing debilitating chronic conditions, as well as the development of more effective treatment for common and rare diseases that affect millions of Americans. Additional information on how NIH funding cuts will harm Massachusetts can be found here.
According to the White House, in the year 2013 alone, Massachusetts can expect to see a reduction in funding for vaccinations of about $201,000, resulting in thousands of fewer children receiving immunizations. In addition, cuts to the AIDS Drug Assistance Program (ADAP) could result in thousands of patients across the nation losing access to life saving HIV medications. The Massachusetts State Department of Public Health will also lose funding, resulting in 9,200 fewer HIV tests in the Commonwealth. The White House’s report on the impact sequestration will have on Massachusetts can be accessed here.
The FDA will also lose a significant amount of its funding- more than 5 percent of its annual budget. These cuts pose a serious threat for the approval of new drugs. The sequester cuts would cause the FDA’s Center for Drug Evaluation and Research (CDER) to face delays in translating new science and technology into regulatory policy and decision-making, resulting in delays in potential life-saving drug approvals.
We look forward to hearing FDA Commissioner Margaret Hamburg’s perspective on this and other issues impacting the FDA at our Annual Meeting next week. The MassBio Annual Meeting is being held March 14-15, 2013 at the Royal Sonesta Hotel.
The introduction of biosimilar and interchangeable biologics into clinical practice will present some new challenges that have not historically been present with small molecule generic medicines. Current state rules on substitution will very likely need to be updated or completely re-written in the context of biosimilar and interchangeable biologic medicines. MassBio’s Annual Policy Leadership Breakfast held in January focused on this very issue.
Listen as our panel discusses the importance of implementing sound policies at the state level to ensure patient safety:
Yesterday, we held the MassBio Annual Policy Leadership Breakfast. Thank you to all of our speakers, sponsors, and attendees for making it a very successful event! We will do an event recap that includes video footage and the panel discussion on biosimilars soon, but today we wanted to be sure to congratulate Senate President Therese Murray who was named the MassBio Legislator of the Year!
Senate President Murray has been proactive in forging strong relationships for Massachusetts with leaders abroad and, this year, led us as we welcomed the BIO International Convention back to Boston. She and her colleagues participated in the Massachusetts Pavilion and met with numerous global companies and organizations to educate them on the benefits of being involved in the leading life sciences cluster in the world, resulting in tangible wins for the Commonwealth and patients everywhere.
Last legislative session Massachusetts legislators passed Senate Bill #2400, An Act Improving the Quality of Health Care and Reducing Costs Through Increased Transparency, Efficiency and Innovation.
The legislation is extensive—and includes provisions ranging from language to ensure patient access to breakthrough technologies, to language to include a biotechnology industry representative on the Advisory Council to the Health Policy Commission.
The law also creates a Cost Containment Commission, tasked with studying methods to reduce the cost of prescription drugs for both public and private payers, including the feasibility of bulk purchasing.
These laws and regulations will impact the life sciences industry in real and long-lasting ways.
Please join us on Monday, November 19th as we host David Seltz, Governor Patrick’s Special Adviser on Health Care Cost Containment, for a discussion on the next steps of cost containment in the Commonwealth.
David is THE go-to guy on this legislation and will share his unique perspective and insight.
This meeting is free and open to all MassBio members and NEHI members. Register for the meeting.
Hope to see you there,
In addition to this year’s notable national policy updates – such as the Supreme Court upholding the ACA, and PDUFA reauthorization being secured through FDASIA – the Massachusetts Legislature voted on some important issues for the biotechnology industry in the 2011-2012 session. Here’s a recap of their decisions on co-pay assistance, the gift ban, and payment reform:
The final Fiscal Year 2013 budget includes co-pay assistance and partial repeal of the gift ban.
On July 8, 2012, Governor Deval Patrick signed into law the Fiscal Year 2013 budget, which includes language that allows Massachusetts residents to take advantage of co-payment assistance programs. Up to that point, Massachusetts was the only state in the nation that banned these programs. The budget also includes language to allow certain interactions between companies and physicians that had been barred under the “gift ban” previously enacted.
The details: FY 2013 Budget – H4200
1. Co-pay assistance – Sections 128, 129, 130, 131, 201 and 226
Allows co-pay assistance programs and discount programs to be used in Massachusetts for prescription drugs and biologics for which no chemically identical generic drug exists.
2. Gift ban – Sections 108-114
Permits pharmaceutical and medical device manufacturers to pay for “modest meals and refreshments” outside of the practitioner’s office or hospital setting in connection with non-CME educational presentations for the purpose of informing practitioners about prescription drugs, medical devices, disease states or other scientific information.