Welcome & Introductions

• District of Columbia Councilmember David Catania, NLARx Chair
• Host, Massachusetts Senator Mark Montigny

One year out: Massachusetts’ Gift Ban, Academic Detailing & Disclosure Law: How is it being implemented? What are the issues?  What are the lessons for other states?

A panel including a Massachusetts regulator, a health care advocate and a legislator who was a leader in the passage of the Massachusetts payment transparency and gift ban law in 2008 discussed the regulations implementing the law. 

• Melissa Lopes, Deputy General Counsel, Massachusetts Department of Public Health – spoke on the challenges of implementing the law and the choices made to limit its scope.
• Georgia Maheras, Private Market Policy Manager, Health Care for All – detailed the specifics of the law and the areas where the regulations fail to carry out the intent, including lack of disclosure of research and limitations on the gift ban. (Download Presentation)
• Massachusetts State Senator Mark Montigny – spoke about his concern that the regulations fail to implement legislative intent.  Of particular concern is the exclusion of research payments from disclosure, the way the $50 gift ban is being implemented (effectively allowing multiple $50 gifts), and the failure to fund the academic detailing program enacted in the law.

Drug Samples: Are they medicine for the uninsured, or a pharma marketing tool?

• Dr. Sarah Cutrona presented on her research, "Free drug samples: Are we helping our patients?" – Patient safety and other concerns plague sample distribution policy and support not only disclosure of free samples but tighter regulation, including simply getting rid of such samples. (Download Presentation | Cutrona et. al. article in Pediatrics, 2008 | Cutrona et. al. article in the Amerian Journal of Public Health, 2007)

PBM Transparency: Will transparency survive health care reform? 

• Attorney David Balto, Senior Policy Fellow at the Center for American Progress spoke on "Reining in PBM Mischief After Health Care Reform."  The health care reform bills include some limited PBM transparency for insurance plans participating in the exchange, but even if these provisions survive into the final law, much will remain for the states to tackle, including enforcing the federal. (Download Presentation)

Legislative Roundtable: State legislators from across the country will discuss their upcoming 2010 legislative agenda, lessons learned from past efforts, and best practices to reduce drug costs and expand access to medicines. Reports from some of the states attending the meeting:

• District of Columbia: The District has already seen early successes with its popular academic detailing program, and has been collecting data on marketing spending and gifts, as well as licensing sales representatives, under its SafeRx Law.  New issues being tackled include therapeutic interchange restrictions.
• Maine: Pending legislation will expand the drug return pilot program and establish product stewardship.  Other pending legislation will close loopholes in the payment disclosure law and implement a gift ban, and improve the effectiveness of the PBM regulatory provisions.  The newly enacted predatory marketing law focused on protecting kids is likely to be repealed but new legislation is being drafted to provide protections without impinging on the First Amendment.  A Corrections Department study looking at 340B options is ongoing.
• Massachusetts: Pending legislation would repeal a current ban on consumer rebate coupons.
• New Hampshire: Data mining companies are talking about trying to repeal the state’s law banning marketing uses.  A bill to fund the academic detailing program may be introduced.
• New York: The political situation in New York has been confused in the Senate and it is unclear whether pending initiatives can go anywhere given the back-and-forth in the leadership.

Predatory Marketing: Social media and marketing to children, and the policy and legal issues states face when trying to regulate.

• Ann Woloson, Executive Director of Prescription Policy Choices, presented “Predatory Marketing: Who's lurking in the shadows of cyberspace?" and highlighted issues related to marketing strategies used by drug companies to access children's personal information, that is in turn used, shared, or sold for marketing purposes. The presentation included information on Maine's new law, which was passed in an attempt to protect kids from such activity. (Download Presentation)

SUMMARY OF WOLOSON PRESENTATION

Most adult consumers would probably be surprised and offended to know their personal information, which most assume to be private, is frequently being purchased, used, shared, and sold by a variety of marketers. Now children are being targeted via the internet and cell phones, by marketers including pharmaceutical companies, that sell and share personal information with other companies who also use the information to market prescribed products.  The Maine legislature passed legislation in an attempt to protect the state's teens from predatory marketing practices, but the law was challenged in court by a number of plaintiffs, including universities and newspapers, who were concerned it is too broad and violates free speech rights under the first amendment. A legislative committee was asked to review the legislation and make suggestions to change it so that it does not prohibit legitimate activities, but still provides the intended protections teens need.  “There needs to be a balance," stated Woloson. "The right to provide and collect information over the internet for legitimate purposes needs to be protected, as does the right to protect children's privacy."

Unused Drugs: Challenges and successes implementing drug return programs. 

• Maine Rep. Anne Perry discussed Maine's mail back program – “Unused Household Pharmaceutical Disposal, Public Law 2003, Ch. 679”

SUMMARY: Since 1960 introduction of new medications to treat severe and chronic have astronomically increased. Approx. 8-10% of household medications are discarded; in 2008 for Class II-IV, Maine dispensed 2,299,736 prescriptions - 1.75 per person. Purpose of Take-Back Program – (1) Remove unneeded prescription drugs from circulation; (2) Disposal in compliance with applicable state and federal laws and sound environmental practices; (3) Phased Implementation - Allows for monitoring of the program and piloting of protocols. (Download Presentation)

• NLARx Executive Director Sharon Treat reports on her tour of Iowa's central repository that redistributes unused long term care drugs, the only program like it in the country.  (Download Presentation | Iowa Drug Donation Repository Annual Report.)