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NLARx News                                                                 November 4, 2011

In This Issue
From the Director
Will the 1st Amendment Trump FDA Off-Label Marketing Restrictions?
Leaked Text Shines Light on Pharma Issues in TPPA
Is someone finally paying attention to PBM problems?
NLARx on Twitter & Facebook
NewsNews Ticker

 

The Diane Rehm Show on Drug Shortages 

 

"Grey Marketer" Clams up on Drug Shortage Issue  

 

Obama Used Executive Order to Address Shortages 

   

Fix the Deficit: Negotiate Drug Prices in Medicare!  

 

An end to big pharma extortion? 

 

 Lipitor Fights Generic Competition with Coupon Campaign

 Xigris Pulled from Market After $1 Billion Spent

New York Tackles Medicaid Fraud by Docs
 
Yaz & Safety: Check this Out

Women Find Pfizer Chapstick Ad Offensive

State Medicaid Spending Skyrockets

FTC: Pay-for-Delay ban Would Save $2.67B

Medicare Drug Plans Get Poor Ratings  

 

Which Drugmakers Overpaid CEOs?

 

Pfizer Nailed Again for Deceptive Marketing 

 

Bipartisan Bill Would Relax Conflict of Interest Policies 

 

Pharma marketing abuses in Australia, too 

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From the DirectorExecutive Director

What's happening in pharmaceutical news, especially as it affects the states?   

** Is free speech a threat to patient safety & privacy?  Drugmakers want to market off-label uses and be free to use private prescriber data to profile doctors to target their messaging.  Read the latest about how the industry is trying to override safety and privacy concerns with free speech arguments. Read more

** Leaked documents including drug pricing provisions were the focus of attention in Lima, Peru in round 9 of negotiations for the next big trade deal, the Trans-Pacific Partnership (TPPA).  Learn what's in the proposed text that concerns states and public health advocates.  Read more

** Antitrust issues and competition in the PBM industry: is someone finally listening? The Express Scripts-Medco merger is getting some needed scrutiny from the FTC and members of Congress. Will someone finally put a stop to this runaway train?   Read more  

 

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Check out the News Ticker for a variety of interesting articles. For regular updates, the best way to stay current is to "like" us on Facebook and follow us on Twitter (we just started tweeting @nlarx).  Keep in touch! Sincerely, Sharon Treat    

 free 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 supportive and disparaging of the US Supreme Court's decision) agreed on its breadth and the potential for litigation expanding the scope of the First Amendment law to limit FDA marketing rules.  BU law professor Kevin Outterson addresses this issue in his post "The Last Drug Company Settlement for Off-Label Promotion" in the 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 text from 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. 

TradeTPP Talks in Peru Focus Pharmaceutical Issues Disclosed in Leaked Text on Pricing and Patent Policies 

NLARx Executive Director Sharon Treat attended the TPP  events in Lima, Peru recently and presented on medicines issues at the official stakeholder 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 talks posted by Knowledge Ecology International. Roberto in Lima

 

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.   

 

A new provision would require drug reimbursement lists such as preferred drug lists to consider new uses for drugs already on the list, even if those new uses have been approved by no countries and are based on a single industry study.  While reimbursing for the new use could be denied, it would have to be justified with a detailed written report and an opportunity to appeal drafted the drug company.  For an example of how this gaming of an evidence-based system could play out, read this article from Australia, "The tricks companies use to get over-priced drugs on the PBS." 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.

  

Read more on these issues:

State resolutions and letters on trade and medicines 

NLARx Resolution opposing  provisions in the TPPA

Vermont Governor Peter Shumlin's letter to President Obama  

Background on trade agreements and pharmaceutical policy

MergerIs 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 Congress recently 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 articlesNo 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, www.pbmwatch.com.    

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