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NLARx News
December 21, 2010
In This Issue
From the Director
NLARx Meeting Details
Focus on Pharma Fraud
FDA in Troubled Waters
In the States
Pharma Watch Around the Web
NLARx on Facebook

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From the Director
Executive Director

 

This issue features a new report by Public Citizen finding the drug industry has surpassed the defense industry as the largest defrauder of the federal government, as measured by False Claims Act settlements.  Such fraud imposes significant costs on state Medicaid programs. States can and should get involved by reguating industry activities, and enacting state versions of the False Claims Act. Check out the Legislators' Toolbox for model bills and policies.

 

State regulation of pharmaceutical policy often is dismissed with "don't worry, the FDA will handle that."  We report on a spate of new articles highlighting the challenges and failures of the FDA, and emphasizing the importance of state contributions in the arena of pharmaceutical policy. These issues and others will be discussed in detail at the NLARx Winter Meeting January 21 in Washington, DC - also a great netwirking opportunity.  See the agenda below.  Its time to register! 

 

As always, we bring you a roundup of state news and a few of the many articles that report on Big Pharma.  Hope this information is useful and of interest!  Sincerely, Sharon Treat

NLARxeventsRegister Now for NLARx Winter Meeting Showcasing State Drug Pricing and Rebate Strategies January 21, 2011 in Washington, D.C.

  

Is your state poised to take advantage of new drug rebate options under the Affordable Care Act?  Make sure you have the tools you need to counter Medicaid budget shortfalls!

 

As states struggle to cut costs while maintaining quality health care for vulnerable residents, now is the time for lawmakers and agency officials to advance common-sense reimbursement reforms. Despite positive policy changes related to Federal Upper Limits and Average Whole Price, many states are still losing out and paying significantly more than other payors for pharmacy services. The result is that providers sometimes retain unjustifiable profits, and there is no accurate way to track that spread. In response, some states have successfully implemented highly effective MAC lists, and others are testing new ground using Actual Acquisition Cost, but state officials are still grappling with the question of how best to ensure Medicaid is paying a fair and transparent price for prescriptions.

 

Speakers & Presentations:

 

Medicaid Pharmacy Reimbursement Reform: Trends and Recommendations
Speakers: Mike Winkelman, Pharmacy Consultant
Nell Geiser, Change to Win Pharmacy Initiative Coordinator

Mr. Winkelman and Ms. Geiser will discuss opportunities for states to achieve a more transparent and accountable Medicaid pharmacy reimbursement system that can result in significant savings.The presentation will include recommended guidelines for reimbursement policy reform and estimates of projected savings if new benchmarks were implemented.

 

Opportunities for Pricing Reform through Pharmacy Benefit Manager (PBM) Regulation
Speaker: David Balto, Center for American Progress, former Federal Trade Commission Policy Director

 

Attorney and antitrust expert David Balto provides background on PBMs and the opportunities to address drug pricing concerns through legislation providing greater transparency and regulating conflicts of interest. Mr. Balto will also discuss whether there are opportunities to regulate PBMs through provisions in the Affordable Care Act and Department of Labor regulations.

 

What States Should Know about International Regulation of Pharmaceutical Pricing Legislation and the Trans Pacific Partnership (TPP)
Speaker: Sean Flynn, Associate Director, PIJIP, Washington College of Law, American University

 

State legislators and officials have been advocating for years that the US Trade Representative refuse the pharmaceutical industry's demands for a new international framework regulating domestic pharmaceutical pricing regulations. The US is now negotiating a new plurilateral trade agreement - the Trans Pacific Partnership - and Big Pharma is again asking for broad-ranging restrictions on domestic price regulation authority.

 

MORE ON THE AGENDA, REGISTRATION & LOGISTICS

fraudPublic Citizen Report: Pharma Industry is Largest Defrauder of the Federal Government under the False Claims Act

 

A Dec. 16 report issued by Public Citizen found that the pharmaceutical industry had surpassed the defense industry as the largest defrauder of the federal government, as measured by False Claims Act Settlements.  The report also notes the costs that pharmaceutical fraud imposes on state programs, including Medicaid. 

 

From the report highlights:

  • Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
  • Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades. These leading violators were among the world's largest pharmaceutical companies.
  • The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects in patients from such activities.
  • Deliberately overcharging state health programs, mainly Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments. This type of violation is also the main factor in the considerable increase in state settlements with pharmaceutical companies over time.

More reading:

Public Citizen Press Release

Full Report: Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010

Pharmalot: Abbott, Two Others Pay $421M Over Pricing Fraud

FDAFDA Faces Troubled Waters

 

State regulation of pharmaceutical policy often faces the dismissal of "don't worry, the FDA will handle that."  A spate of new articles highlights the challenges and the failures of the FDA, and emphasizes the importance of state contributions to the arena of pharmaceutical policy.

Report criticizes the FDA's Office of Criminal Investigation

In a Byzantine series of investigations, the GAO produced a report on the FDA's office of criminal investigation.  Then the GAO faced accusations that the report and the investigative process were compromised by a tip to OCI officials.  The GAO then launched a review of the report.  All of this took place against the backdrop of the head of OCI, Terry Vermillion facing accusations of inappropriate work travel expenses, personal use of staff, and payments for training for an "office mistress."

Full Pharmalot coverage of the GAO/OCI debacle:

GAO Denies Problems With Report On FDA's OCI

FDA, An Office Mistress & A Compromised Report

What Mistress? The FDA's Top Cop Is Retiring

GAO Report: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations

Pharma and Device Industry Share Low Opinion of FDA

While the FDA often faces justified criticism that the user-fee structure creates too much accountability to the pharmaceutical companies and device manufacturers that the agency is tasked to regulate, recent news discloses that these industries aren't thrilled with the FDA either.  A Pricewaterhouse Coopers report surveyed 50 regulatory affairs officers at top companies and found that there were significant doubts about the FDA's ability to carry out agency directives, including very low confidence that the FDA was equipped to handle the growth of personalized medicine as a pharmaceutical growth area.

As part of the study, PWC also polled laypeople to judge their perception of the FDA as a counterpoint to the industry perspective.  Less than 50% of those polled believed that either FDA or the pharmaceutical industry were doing enough to prevent adverse events.  Further, 58% of respondents believed that politics has too much influence on drug approval decisions.

Pharmalot: What Does Pharma Think Of The FDA? Not Much

Pricewaterhouse Cooper: Report: Improving America's Health V

WSJ Health Blog: FDA Medical Device Review Process: Too Fast or Too Slow?

statesIn the States

Stateline:Stitching Medicare and Medicaid Together
California: SF Mandates Disposal of Drugs

Minnisota: Minnesota to Change Course on Health Care for the Poor

In Minnesota, Drug Company Reports of Payments to Doctors Arrive Riddled With Mistakes 

Missouri: Gov. Nixon Campaigns for Missouri Rx Program

pharmawatchPharma Watch Around the Web

AMA News: Prescription Requests May Rise Under New OTC Drug Payment Provision
Reuters:Supreme Court to Decide Generic Drug Labelling Issue
Bloomberg: Google, Microsoft Join Obama to Combat Knockoff Drugs

Drug Store News: In Landmark Victory for Retail Pharmacy, Feds Agree to Drop Last AMP Provisions

WSJ: Europe's Drug Regulator Says Innovation Must Pick Up

Bloomberg: U.K. Starts Consultation on 'Value-Based' Drug Prices

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