Life Science Compliance Update

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32 posts from June 2009

June 30, 2009

Health Care Reform: Obama, AARP and PhRMA Offer Help to Seniors

With comprehensive health care legislation only being “discussed” on the House side, and with the Senate Finance Committee yet to publish their “discussion” on health care reform, the new $80 billion agreement between the Obama administration and pharmaceutical companies is interesting.

According to the Wall Street Journal “The $80 billion deal announced last week between drug makers and Washington Democrats highlights a problem within the Medicare Part D Drug Benefit: The doughnut hole.”

This “doughnut hole” refers to the gap in coverage that leaves beneficiaries on the hook for the cost of prescription drugs when the cost of their prescription drugs passes $2,700 in a year. Coverage is then returned when a beneficiary’s annual drug cost passes $6,154 in a year, in which "catastrophic" coverage kicks in and covers nearly all drug expenses. As a result of these gaps, for one quarter of Medicare beneficiaries, about 15% stop taking their medicine.

The $80 billion in revenue over a decade would largely cover more of the cost of brand-name prescription drugs under the federal government program for seniors, and “it would make up part of the $313 billion in government health-spending cuts.

-                           The proposal would cause drug makers to pay half (50%) of the cost of prescription drugs when Medicare beneficiaries are in the “doughnut hole.”

-                           The proposal also offers other unspecified discounts and rebates or medications purchased through the Medicaid program or those for seniors enrolled in Medicare managed-care plans.

-                           The full price of the drug would count toward a person's out-of-pocket total, thus maximizing the insurance benefit.

-                           Those earning more than $85,000 a year -- would probably continue to pay full price, according to an industry source.

President and CEO of PhRMA applauded Chairman Baucus and President Obama on putting together the agreement, as did Barry Rand, chief executive of AARP. However, AARP’s still wants to “close the doughnut hole entirely.”

Consequently, there are still a lot of unknowns about who else will benefit from the deal, and what portion would accrue to the federal treasury. Moreover, the deal is contingent upon overwhelming health care reform legislation actually getting passed.

Another concern about the deal is how much the government will get from the deal to pay for covering the uninsured. Furthermore, not all of the $80 billion will go to offset the costs of covering the uninsured. An estimated $30 billion, which represents the approximate lost revenue from all prescriptions filled by this group, will help pay for the gap in Medicare prescription drug coverage.

The remainder of the contribution, approximately $50 billion, will go to new subsidies to provide to the uninsured—a total estimated at least $1 trillion over a decade. Accordingly, PhRMA has “been reluctant to detail how much money would be dedicated to each piece of the puzzle, and it did not know what the split would be.”

Some assert that the deal won’t affect the bottom line of drug companies because it “will ultimately discourage patients in the donut hole from switching to generics," because their out-of-pocket costs for brand-name drugs will be less. Many analysts estimate expanded insurance coverage (which PhRMA is advocating for) could increase yearly drug sales in the U.S. by $9 billion to $12 billion, or 3% to 4% of annual sales.

If health-care reform legislation is enacted, the agreement would bring financial relief to about 3.4 million elderly and disabled Americans, and could save 3.5 million retirees up to $1,700 a year, according to AARP.

 

Ultimately, with a health care plan that has yet to been finalized for public comment, and only $50 billion in savings for over $1 trillion in spending, Obama and his health care team have a long way to go.  While addressing the gap in Medicare for prescription drugs is certainly a very important effort, and will ultimately reduce spending and cost in the health care system, the plan may still be unaffordable.

 

Democrats and Obama need to look for more ways at spending less money from taxpayers, and still save seniors money.  In other words, even if Obama or AARP say they are saving money for seniors, that money saved is going to be taken right out of their pockets and the pockets of their grandchildren in order to pay for this plan. Most likely, Congress will not even get to debate the health care legislation before August, let alone this deal.

June 29, 2009

FDA: Transparency Taskforce -- Industry + Anti Industry (No middle ground)

This past week the FDA held their first Transparency Taskforce meeting headed up by Deputy FDA Commissioner Joshua Sharfstein.  The interesting thing about the meeting is those that presented were either industry groups or anti-industry, but little representation from the middle.

This is not surprising given that Sharfstein’s early carrier included stents with Congressman Henry Waxman (D-CA) and the Ralph Nader Group (Public Citizen's Health Watch).

Industry groups included AdvaMed, PhRMA, Natural Products Association, Device Manufactures Association, Biotechnology Industry Association.  

Anti Industry groups include: Consumers Union, Pew Prescription Project,  Natural  Resources Defense Council, Public Citizen, The Senior Citizens League, and Center for Science in the Public Interest.

It is disappointing for the low representation from researchers, educators, and real patient organizations.  But this is largely because the groups speaking sent in the longest comments.  Everyone agreed that the FDA needs more transparency, it is all in how you define that transparency.

To link to any of the presentations:

Welcome and Introductory Comments
Joshua Sharfstein, MD, Principal Deputy Commissioner
Afia Asamoah, JD, MPP, Special Assistant to Principal Deputy Commissioner

Panel 1
Janet Trunzo, AdvaMed
David Lim, Independent Consultant

Panel 2
Jeffrey Francer, PhRMA
Kristi Zonno, MS, CGC, Genetic Alliance

Panel 3
Steven Findlay, Consumers Union
Bray Patrick-Lake, Consumer
Allan Coukell, Pew Prescription Project

Panel 4
Daniel Fabricant, Ph.D, Natural Products Association
Sarah Janssen, MD, Ph.D, Natural Resources Defense Council
Kathy Means, Produce Marketing Association

Panel 5
Bob Kelser, IDSN, Inc.
Kathryn Foxhall, Freelance Reporter

Panel 6
Shannon Benton, The Senior Citizens League
Peter Lurie, MD, MPH, Public Citizen
Diana Zuckerman, Ph.D., Nat’l Research Center for Women & Families

Panel 7
Mark B. Leahey, Medical Device Manufacturers Association
Nancy Beck, Ph.D.Physicians Committee for Responsible Medicine
Sin Hang Lee, MD, Milford Medical Laboratory

Panel 8
Emily Claire Napalo, Breast Cancer Fund
William H. Maisel, MD, MPH, Medical Device Safety Institute
Andrew Emmett, Biotechnology Industry Organization (BIO)

Panel 9
Sarah Klein, The Center for Science in the Public Interest
Kiyo Oden, The Tatia Oden French Memorial Foundation
Carolyn Brubaker, Microsoft

Open Comment Session

June 26, 2009

Letters from Grassley: 23 Universities Get Letters

In a serious over reaction, the Ranking Member of the Senate Finance Committee, Senator Charles Grassley (R-I) sent out letters to 23 medical schools who failed to fill out a survey by the American Medical Students Association.

 

The survey conducted by AMSA, is used to grade universities based on the conflict of interest policies and published as a score card.  The score based on PharmFree criteria designated by AMSA and has nothing to do with science or patient care, but rather are you “pure” in their eyes.

 

Instead of the Senator asking for reasons why the survey was not filled out (let me think, students sending a survey?  That has to fall on some ones desk and to the bottom of the priority list).

 

He is asking for the schools that did not respond for conflict of interest policies along with records of all their grants.

· A copy of your institution's policy on employee conflict of interest.

· Please provide any notifications and/or communications to the NIH regarding conflicts of interest and research by professors at your institution.  This request covers the period of January 1, 2004 through the present.  

· Please provide a total dollar figure for all NIH monies and/or other federal monies annually received by your institution.  This request covers the period of 2004 through 2008. 

· Please provide a list of all NIH grants and/ or other federal grants received by your institution.  This request covers the period of 2004 through 2008.  For each grant please provide the following:

a.    Primary Investigator;

b.    Grant Title;

c.    Grant number;

d.    Brief description; and

e.    Amount of Award.

 

They have until July 15th to send in all this information.

 

The following are the schools that the senator is targeting with letters:

· The Arizona College of Osteopathic Medicine,

· Edward Via Virginia College of Osteopathic Medicine,

· Medical College of Georgia School of Medicine,

· Northeastern Ohio University College of Medicine,

· Philadelphia College of Osteopathic Medicine,

· Rocky Vista University College of Osteopathic Medicine,

· Tulane University School of Medicine,

· University of Florida College of Medicine,

· University of Nevada School of Medicine,

· Albany Medical College,

· Chicago College of Osteopathic Medicine,

· Dartmouth Medical School, Howard University College of Medicine,

· Lake Erie College of Osteopathic Medicine,

· Louisiana State University School of Medicine - New Orleans,

· Meharry Medical College,

· Morehouse School of Medicine,

· New York College of Osteopathic Medicine of the New York Institute of Technology,

· Ponce School of Medicine,

· San Juan Bautista School Of Medicine,

· University at Buffalo School of Medicine,

· University of Medicine and Dentistry New Jersey - New Jersey Medical School,

· University of South Carolina School of Medicine

 

The question should be asked, what constitutes a medical schools responsibility? 

Is it the responsibility to answer a student survey – especially a student group like

AMSA?

 

Is this the proper use of power to send out press releases that you have opened an investigation based on not answering a student’s survey?  

 

Congress does have the ability to ask questions, and the first question may have been to ask why the survey was not filled out.

 

There comes a point when we see abuses of power, and these letters come very close to crossing that line.

 

Universities need to remember “Senator Grassley is Watching”

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