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From the Director:
 Its been an interesting couple of weeks. Here's the news:
- Congress actually might enact compounding safety legislation, through some states aren't waiting...Read more
- Big news on the TPP trade deal... just-leaked text shows drug prices will go up, AARP and other groups are raising concerns, health activists worry about NSA surveillance, and Congress is getting squirrelly about fast-tracking the deal. Read more
- Importation has gotten a boost from Maine's new law clarifying its pharmacy board's authority, with lots of national media coverage. Read the legal briefs and judge for yourself whether Big Pharma has a strong case against the state. Read more
- States continue to address a variety of prescription drug issues including take-back and drug disposal laws, PBMs, big settlements with the drug industry over illegal marketing and pricing, and biosimilar drug substitution. More
Check out this report from the Commonwealth Fund on Germany's comparative benefit assessment of drugs and lessons for us in the US.
Keep up with the news! Remember, in this fast-paced world the most up-to-date news about state pharmaceutical policy is posted in our Twitter feed (@nlarx) and Facebook page. We also regularly post news stories and links to reports and testimony on our
 
Best wishes,
Sharon Treat, Executive Director
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 Will Congress Finally Act on Compounding Safety?
Congress: Yesterday Pharmalot reported that the US Senate could vote as soon as today to enact new compounding safety legislation giving FDA greater authority, despite the fact that Senator David Vitter tried to hold the bill hostage to his hatred of Obamacare. Here is a summary of the bill as passed by the House. Problems continue across the country, such as this article on a Michigan pharmacy which fungal contamination, reported just last week, and this article on problems with the labs that test compounded drugs. The bill has been subject of lots of lobbying, with big money being spent, according to Politico.
States: It will be interesting to see if state legislatures will continue to enact safety compounding laws when the 2014 sessions get underway. According to a report of the National Conference of State Legislatures (NCSL), as of October 15, 2013, there have been a total of 27 bills or resolutions filed across 16 states which relate to compounding pharmacies, with measure adopted or enacted into law only in California, New Hampshire, Minnesota, Maryland, Virginia, Georgia, Tennessee, Texas, and Utah. Maine enacted legislation which was vetoed.
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Big News: Somebody Leaked the TPP Intellectual Property Text, and Now Everyone Can See How the TPP Could Hike Drug Costs for Consumers
Yesterday, multiple organizations released links to a leaked August 30, 2013 text that purports to be under consideration in the Trans-Pacific Partnership Intellectual Property Chapter. The IP chapter has implications for pharmaceutical prices and the availability of generics both in the US and in developing countries that are part of the 12-country Trans-Pacific Partnership (TPP). Negotiations on this sweeping treaty have been underway for three years and the Obama Administration is seeking to wrap up the 12-country deal by the end of 2013.
Several organizations have posted their analysis of the IP chapter, how it compares to an earlier version leaked several years ago, and what the positions of the different countries might mean:
One thing is clear, and this leak only confirms what we already knew: US negotiators are standing in the shoes of Big Pharma seeking long-term monopolies even on "me too" drugs, and pushing for provisions that will delay generics-- puzzling since this flies in the face of the affordable healthcare agenda of the Obama Administration. Here is the still-relevant NLARx resolution on the TPP and pharmaceutical prices.
The leak comes on the heels of a couple of interesting developments. Late last month, 14 civil society groups including AARP, the American Federation of State, County and Municipal Employees (AFSCME), and Consumers Union and other U.S. health and consumer advocacy groups wrote to President Obama expressing "deep concern" that TPP rules will thwart efforts to control escalating healthcare costs. Read the letter and this Global Trade Watch Blog. In addition, over 80 law professors called for greater transparency in the negotiations. Meanwhile, a New York Times article on NSA spying on communications of US citizens at the behest of a variety of agency "customers" including the US Trade Representative prompted a letter of concern from organizations engaged as stakeholders in the TPP negotiations (including NLARx).
Just yesterday, other questions have been raised by members of Congress, who have the final say on whether to agree to the TPP, with letters from both Republican and Democratic members opposing "fast track" consideration of the TPP - all told, more than half of the House.
Not leaked this time around is another problematic TPP Annex under consideration, confusingly and inaccurately named the "Healthcare Transparency" Annex, which could affect state and federal Medicaid, 340B and Medicare Part B prescription drug purchasing and reimbursement. A version of this text was leaked in 2011 and analysis can be found in the Maine Citizen Trade Policy Commission's 2012 assessment of trade impacts and in NLARx Executive Director Sharon Treat's analysis of implications for state medicaid programs. This paper by Prof. Deborah Gleeson explains how similar provisions in prior treaties with Australia and Korea compare makes the case that drug costs will go up if this Annex becomes part of the TPP.
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Maine's Importation Law Gets Lots of Attention
As previously reported, Maine has enacted legislation allowing personal importation of prescription drugs from several English-speaking countries with high safety and oversight standards. On September 10, PhRMA and allies including several pharmacy groups challenged the law seeking an injunction barring its implementation; here is the complaint. Now the Maine Attorney General has fired back with her responses, and we find the arguments persuasive. Read the Memorandum in Opposition and Maine's Motion to Dismiss. Maine makes clear that its law clarifies the scope of its pharmacy board's jurisdiction and is not an attempt to change or subvert federal law - whatever that may be, and its a somewhat murky area. The fact is, Maine businesses and the City of Portland facilitated employees' personal importation for many years without problems or challenge.
This excellent PBS Newshour report interviews the businesses who sought a clarification of state law and the conservative Republican state senator who sponsored one of the bills introduced on the subject. CBS News also reported on Maine's law. As always, Pharmalot has thoughtful reporting on the story. We will see if any other states follow suit in the next legislative session.
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Other News in the States
And the fraud goes on: In addition to compounding safety, states have been acting on a wide range of pharmaceutical issues. 40 states and the District of Columbia settled fraud lawsuits with Johnson & Johnson and its Janssen Pharmaceuticals, Inc. subsidiary for illegal promotion of two of its best selling antipsychotic medicines, Risperdal and Invega, including the states of Hawaii, Ohio ($52.7 million!), Missouri ($26 million), Massachusetts ($62.5 million), and Florida ($1.6 billion!!!). All told, the company is looking at paying $2.2 billion for its actions. Wisconsin has settled with McKesson for drug pricing fraud, recouping nearly $14 million.
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