Life Science Compliance Update

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4 posts from February 23, 2010

February 23, 2010

University of South Florida: Nobel Prize Winner Lectures on Working with the Pharmaceutical Industry


Many medical schools are running away from industry, but one university is embracing the outcomes of working with Industry.  The Dean of the University of South Florida is hosting on March 4th Nobel Laureate Alfred Gilman, MD, PhD in a lecture titled:

USF Deans Lecture

Why is Everyone Picking on the Pharmaceutical Industry

And Yes, I have a Financial Conflict of Interest

A pro and con discussion of the pharmaceutical industry’s current status,

Including consideration of public affairs issues

Cocktail Reception: 5:00pm-7:00pm

Lecture: 7:00pm-8:00pm

Sponsored by USF Health

In addition they are also holding a panel discussion on the important topic of transparency and objectivity:

Tenth USF Symposium on Bioethics Conflicts of Interest

Balancing Entrepreneurship with Objectivity and Transparency

University of South Florida Discussion with Alfred Gilman, MD, PhD

Panel Discussion: 3:00pm-5:00pm

Jointly Sponsored by

USF Division of Research Integrity & Compliance &

USF Bioethics and Medical Humanities


For more information and to register visit


No registration fee for these activities.

Registrations must be received by March 1st

About Lecturer:

Alfred Gilman, MD, PhD

1994 Nobel Laureate in Physiology or Medicine

Alfred G. Gilman, MD, PhD co-founded Regeneron Pharmaceuticals, Inc and is currently the Chief Scientific Officer of the Cancer Prevention and Research Institute of Texas.

He served as Executive Vice President for Academic Affairs and Provost at the University of Texas Southwestern Medical Center in Dallas as well as Dean of Southwestern Medical School. Dr. Gilman is an American biochemist who shared the 1994 Nobel Prize in Physiology or Medicine with Martin Rodbell for their discovery of G-proteins and their role in signal transduction within the cell.

He received a Bachelor of Science degree summa cum laude in Biochemistry from Yale University and his Doctor of Medicine and Doctorate in Pharmacology degrees from Case Western Reserve University in Cleveland, Ohio.

Dr. Gilman has been the recipient of many awards including the American Heart Association Basic Science Research Prize in 1990, American Cancer Society Medal of Honor in 1995, Albert Lasker Basic Medical Research Award in 1989, and The Gairdner Foundation International Award in 1984.


Obama Health Care Plan: Optimistically Short on Details

In anticipation of the health care summit this Thursday and as promised, President Obama “unveiled proposed healthcare legislation that includes provisions designed to improve access to prescription drugs and increase generic drug availability.” The overall total spending for the bill expected to cost $950 billion over 10 years and provide coverage to more than 31 million uninsured Americans.

The bill also includes an increase in the fees the pharmaceutical industry pays starting in 2011. The increase is expected to help close the Medicare "donut-hole" gap for prescription drug coverage, “which leaves seniors paying the full cost of medicines.” In fact, Mr. Obama’s plan this time completely closes the gap, a change from the bill passed in the House in December.

Consequently, his new proposal increases requirements on the pharmaceutical industry over 10 years by “$10 billion above the $23-billion increase proposed under the Senate bill.” These fees however, will not be implemented until 2011. To support these changes, the administration asserted that the increased money will result in expanding health coverage and closing the donut hole, giving the pharmaceutical industry new revenue.

With regards to the drug industry as well, Obama’s proposal gives the Federal Trade Commission the authority to address the practice of "pay for delay" agreements between brand name and generic drug manufacturers. In doing so, the President hopes to increase access to generic drugs.

The particular provision would prohibit “generic drug manufacturers from accepting anything of value from a brand-name manufacturer that contains a provision in which the generic drug manufacturer agrees to limit or forgo research, development, marketing, manufacturing or sales of the generic drug." Such deals could only be reached if the parties "demonstrate by clear and convincing evidence that the pro-competitive benefits of the agreement outweigh the anti-competitive effects of the agreement."

Other features include:

· Taxes on high value insurance plans

· Mandates on Individuals to buy insurance

· Employer mandates with fines of up to $2,000 per employee

· Medicare taxes on investment income (this will go over big with the AARP crowd)

· Regulated insurance premiums

While the plan will be debated Thursday at the bipartisan healthcare summit, many Republicans are angered. House Republican leader John Boehner said Obama was “undermining the Feb. 25 meeting by proposing the same massive government takeover of health care based on a partisan bill the American people have already rejected.”  Ultimately, this attempt for an “opening bid” for the health care summit may end up being the only bid.

The president’s proposal is surprisingly short (25 pages, utilizing short narrative paragraphs) in comparison, the House and Senate bills are each over 2,000 pages long.    One would hope that the president’s bill would be shorter and presented soon after the summit.  The plan is optimistic but short on details.

Links to Proposal and Key Documents

White House Summary of Health Care Reform Proposal

White House Key Documents

Wall Street Journal

President Obama’s Health Care Summit: Republican Alternatives

While health care reform has been on the backburner since the election of Republic Senator Scott Brown (R-MA) ended the Democrats supermajority, President Obama is hoping to work with Republicans to save the health care bill.

This Thursday February 25, lawmakers from both parties are scheduled to go to Blair House, across the street from the White House, for a televised clash of health policy ideas. According to the New York Times, the White House planned this meeting as a “strategy to intensify its push to engage Congressional Republicans in policy negotiations, and to share the burden of governing and put more scrutiny on Republican initiatives.”

Mr. Obama challenged Republicans to attend the meeting with their plans for lowering the cost of health insurance and expanding coverage to more than 30 million uninsured Americans. Republican leaders said they welcomed the opportunity and called on Democrats to start the debate from scratch, which the president said he would not do.

Republicans are planning to propose making health insurance more widely available and affordable, by emphasizing tax incentives and state innovations, with no new federal mandates and only a modest expansion of the federal safety net. Some of the Republican goals for health care reform include:

- Not requiring employers to provide insurance.


- Opposing the Democrats’ call for a big expansion of Medicaid  

- Allow insurance companies to sell policies across state lines


- Offer federal money as a reward to states that achieve specified reductions in premiums or in the number of people without insurance.  

- Offer federal money to states to establish and expand high-risk pools, for people with chronic illnesses who cannot find private insurance at an affordable price.


- Changes in state medical malpractice


- Expand the use of health savings accounts, to cover routine expenses for people who enroll in high-deductible health plans.


- Expand the role of private insurance companies in Medicare.


- Help small businesses band together and buy insurance through trade associations and professional societies.

Some Republicans, like Senator Tom Coburn of Oklahoma and Representative Paul D. Ryan of Wisconsin, would replace the tax-free treatment of health benefits with a refundable tax credit for the purchase of insurance. They would also encourage the use of state health insurance exchanges.

Republicans and Democrats agree on the need to emphasize wellness and preventive health programs; to provide more transparency for price and quality data on doctors and hospitals; and to speed the approval of lower-cost generic versions of high-cost biotechnology medicines. Both parties also agree to require insurers to let dependent children stay on their parents’ policies through age 25 or 26, and to offer tax credits for two years to businesses with 25 or fewer employees to help them buy coverage.

Senator Lamar Alexander of Tennessee, the No. 3 Republican in the Senate, said Republicans favored “a step-by-step approach” focused on lowering health costs for families and businesses.

Senator Judd Gregg of New Hampshire, the senior Republican on the Budget Committee, suggested that there are two plans that could serve as a basis for compromise: a proposal that he developed called “Coverage, Prevention, Reform” — C.P.R., for short — and a bill put forward by Senators Ron Wyden, Democrat of Oregon, and Bob Bennett, Republican of Utah. His own plan is described in an op-ed piece on Yahoo with further details provided on his Web site (pdf), and Mr. Wyden and Mr. Bennett’s bill would end the tax exclusion for employer-provided health benefits and provide more choice and flexibility for consumers (pdf), including those who already have insurance.

Most media report that it is not clear that Republicans and the White House are willing to negotiate seriously with each other, and Mr. Obama has rejected Republican demands that he start from scratch in developing health care legislation. With the meeting shortly approaching, and Congress getting ready for mid-term elections, this may be the last full effort to keep the health care debate alive.

After Thursday’s summit we will know more.


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