1) CHC, MassBIO and PhRMA Support Mass. Emergency Amendments to Allow Modest Meals at Non-CME Events – Cohealthcom.org – 10/22/2012
At a hearing held Friday in Boston by the Massachusetts Department of Public Health, representatives from the Coalition for Healthcare Communication, the Massachusetts Biotechnology Council (MassBio) and the Pharmaceutical Research and Manufacturers of America (PhRMA) testified that the state’s emergency amendments making an exception to a 2008 gift ban to allow “modest meals” to be offered to healthcare professionals is both supported by their organizations and in line with industry and federal standards. Link
2) Nobel Prize-Winner’s Stem Cells Help Glaxo Pinpoint Risks – Bloomberg Businessweek – 10/22/2012
GlaxoSmithKline Plc is applying Shinya Yamanaka’s Nobel Prize-winning discovery in stem cells to identify heart risks linked to experimental drugs earlier in the development process. Yamanaka was awarded the Nobel Prize in medicine this month for his work in turning ordinary skin cells into induced pluripotent stem, or iPS, cells with the potential to become any cell in the body. Link
3) Shire CEO to step down, company names replacement – Mass High Tech – 10/25/2012
After more than a decade at the company, the last four years at the helm, Angus Russell will retire from his post as CEO of Shire, the Irish drug maker with $4 billion in 2011 revenues and a large presence in Massachusetts. Link Read the rest of this entry
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.
Payment Reform includes access to breakthrough technologies.
1. MassBio Commends Governor, Lawmakers for Ensuring Patient Access, Physician Education
MassBio applauded Governor Patrick and the state legislature for including provisions in the Fiscal Year 2013 budget that allow Massachusetts residents to take advantage of co-payment assistance programs and ensure appropriate relationships between industry and providers.
2. Obama Signs FDA Bill Tying User Fees to Reforms
President Barack Obama Monday signed into law the bipartisan FDA bill that sailed through both chambers of Congress last month—a measure that includes a fifth five-year authorization of the Prescription Drug User Fee Act (PDUFA V), and provisions that expand the categories of drugs for which the agency will allow faster reviews and decisions.
3. Harvard and Janssen team up on deal worth up to $300M
The Harvard University lab of Douglas Melton has entered into a diabetes partnership with Johnson & Johnson subsidiary Janssen Pharmaceuticals, Inc. and German biotechnology company Evotec. It could be worth up to $300 million if an approved diabetes drug results from the deal. The deal includes an upfront payment of $8 million and proceeds will be shared between Harvard and Evotec.
Policy Update: MassBio Commends Governor, Lawmakers for Ensuring Patient Access, Physician Education
The first was a partial repeal of the Massachusetts gift ban law enacted two years ago. The second was language that allows Massachusetts residents to take advantage of co-payment assistance plans offered by the industry to help defray the sometimes high-cost of medicines. Until now, Massachusetts was the only state in the nation to not allow such assistance programs, and MassBio has been working to correct that for years.
We thank all of our members who have advocated on these issues, as well as Governor Patrick and the legislative leaders in Massachusetts for their commitment to the industry. Below is a statement we released yesterday following the bill-signing at the State House.
MassBio Commends Governor, Lawmakers for Ensuring Patient Access, Physician Education
July 8, 2012 (CAMBRIDGE, MA) — MassBio applauded Governor Patrick and the state legislature for including provisions in the Fiscal Year 2013 budget that allow Massachusetts residents to take advantage of co-payment assistance programs and ensure appropriate relationships between industry and providers.
“We strongly commend Governor Patrick for signing the FY2013 budget, addressing two important issues – industry/provider interaction and patient access. This sends a message that Massachusetts is truly the leader in life sciences,” said Robert K. Coughlin, President & CEO of MassBio, which represents 600+ life sciences companies and organizations in Massachusetts. “We are not world leaders by accident, but because of leaders like Governor Patrick, Speaker DeLeo, Senate President Murray and their dedicated members—who went through a thoughtful and deliberate process in which they were determined to get it right – and they did.”
Don’t forget to check out MassBio’s Spring 2012 Newsletter!
1. Pharma gift ban isn’t squelching science, yet BBJ – 4/13/12
The Gift Ban succeeded in getting rid of pens and mugs with company names on them. It has embarrassed more than one local doctor who has been told he cannot take a yogurt or a bag of chips at a conference. Link
2. Head of BIO advocates FDA chief innovation officer Mass High Tech – 4/18/12
The head of the leading biotechnology trade group, the Biotechnology Industry Organization (BIO), was in Boston this week, ahead of the group’s annual meeting, taking place at the Boston Convention and Exhibition Center from June 18 to June 21. Link
3. With Flat Budget Proposed, Clamor Builds in Congress for More NIH Spending GEN – 4/18/12
This election year wouldn’t appear to offer much hope for real year-over-year growth in the NIH budget, with both sides of the political spectrum attacking sky-high federal spending. President Barack Obama is proposing to keep NIH’s budget flat in FY 2013 at $30.702 billion in discretionary budget authority from Congress and $30.86 billion in overall program level funding. Link