Will the Drug Industry Get its Heart's Desire and Soon be Able to Market Off-Label and Every Other Way?

The pharmaceutical industry is getting ready to bootstrap from the Supreme Court's IMS v. Sorrell decision overturning New Hampshire's privacy rules on datamining to get rid of the pesky FDA rules limiting their marketing activities to approved uses of drugs. As the Wall St. Journal reported recently, industry attorneys are gearing up to challenge longstanding FDA regulations that have been the source of dozens of legal settlements and even criminal convictions for deceptive marketing, most recently when Glaxo Smith Kline agreed to pay $3 Billion to the US government earlier this week to settle civil and criminal charges in the marketing of Avandia. Read the Pharmalot post and this article on Par Pharma.

This should be no surprise to anyone participating in the symposium on the Sorrell decision held last month at New Hampshire Law School, co-hosted by the Vermont Law School, where legal scholars and practitioners both supporting and disparaging of the US Supreme Court's decision agreed on its breadth and the potential that further litigation could expand the scope of the First Amendment to limit FDA marketing rules. Law professor Kevin Outterson addresses this issue in his post "The Last Drug Company Settlement for Off-Label Promotion" in his blog The Incidental Economist.

By the way, the industry is not going be content with letting this issue percolate through the courts. Leaked US negotiating textfrom recent TPPA trade negotiations (see more on this below) would require countries to allow drug companies to post "true information" on their websites and link to any other website in existence - including social media where so many problems have already cropped up.

For more information:

Sharon Anglin Treat, NLARx Executive Director

207-622-5597

streat@reducedrugprices.org

See this Story in NLARx's Advertizing & Marketing News

Is anyone listening? Will the Feds Finally Do Something about Antitrust Problems in the PBM Industry?

There's plenty of attention being paid -finally!- to the super-concentration of the pharmacy benefit manager (PBM) marketplace, and the latest merger. The federal Trade Commission (FTC) is in the middle of an investigation of the proposed Express Scripts-Medco merger, which would create the nation's largest administrator of drug benefits if federal regulators sign off. The FTC investigation could last several more months (details are confidential). There are 33 state AG offices led by Pennsylvania that are looking into the merger, and there will be a Senate Judiciary hearing in early December. A House committee held a similar hearing last month and 14 members of Congressrecently signed a letter of concern to the Federal Trade Commission. The powerful industry isn't taking this lying down, and is out lobbying in force on Capitol Hill. Read this article about "dueling lobby days." Consumer groups as well as community pharmacists have led the fight against the merger, with a recent press conference and the formation of a national coalition, not to mention op-ed articles. No wonder Medco is championing robots over pharmacists! NLARx signed a letter with other national consumer groups opposing the merger earlier this year. Want to stay up to date on merger action and reaction? Go to a new website, http://r20.rs6.net/tn.jsp?llr=dxiucccab&et=1108455173285&s=0&e=001dnQC3_70n_JIq3I7-chWAcw7yLzl7QnI77l1TF4MqRSuJGjiikHDWmvfdjXbCYLNFu5lrnI-0VaVSpfYCACd0beHuTVu9Bii.

For more information:

Sharon Anglin Treat, NLARx Executive Director

207-622-5597

streat@reducedrugprices.org

See on Pharmacy Benefit Managers news page

Trans-Pacific Partnership Talks in Lima, Peru Focus Attention on Access to Medicines Issues Disclosed in Leaked Text on Pricing and Patent Policies

NLARx Executive Director Sharon Treat attended the TPPA stakeholder events in Lima, Peru last month and presented on medicines issues at the official forum October 25. The talks include nine Pacific Rim nations, including the US, but could expand to include as many at 22 nations before the ink is dry on a final deal, with Canada, Japan and the Philipines poised to get involved soon, according to US negotiators. Here is a nice roundup on the Peru talksposted by Knowledge Ecology International. While the trade talks haven't received much media attention here in the US, they are a big deal in Peru where health advocates worry that the trade deal will make drugs unaffordable, and in New Zealand, where the national Pharmac program, under which New Zealanders can purchase most drugs for a few dollars a script, is exceedingly popular (see this "Pharmac attack" web posting.) Leaked negotiating text was posted on the Internet during the Lima talks, including texts on healthcare transparency and pricing and intellectual property. The leaked provisions are somewhat similar to the Korea and Australia agreements and raised many concerns among access to medicines groups, state legislators, and even law professors. More For complete leaked text, relevant documents and analysis, we recommend the InfoJustice website as well as Public Citizen's Access to Medicines Campaign. Read Sharon Treat's statement on the leaked text here. NLARx, state legislators and other state officials have raised concerns about both procedural and substantive provisions in the Australia and the Korea FTAs, which include pharmaceutical provisions that could conflict with the effective implementation of Medicaid and reduce access to affordable medicines under 340B and other programs. Although the Australia FTA's pharmaceutical provisions [Annex 2-C] and now the Korea agreement are a done deal, the Trans-Pacific Partnership Agreement is still being negotiated, and thus is still open to change. While state legislators were able to convince the USTR to include a footnote in in the Korea FTA "carving out" Medicaid from its provisions, we continue to have concerns because this carve-out does not include other important programs such as 340B, and because the FTAs would essentially lock the US into the current way of pricing drugs in Medicare Part D and call into question reforms in the Affordable Care Act. From the leaked text, it is impossible to know whether the USTR intends to carve out Medicaid, expand the carve-out to other programs, or delete the carve-out altogether, and the USTR's chief negotiator did not answer a question about the carve-out at the stakeholder briefing in Lima. For more information:Sharon Anglin Treat, NLARx Executive Director207-622-5597streat@reducedrugprices.org