October Edition

Articles:

Capitol Hill Update

Groups Call for $200M in Federal Funding for HIV/AIDS Prevention


PhRMA Hands Out Codes

 

 Capitol Hill Update

Congressional Agenda:  The End is Near?

As Congress prepares to leave town and begin the last round of campaigning before the November elections, funding for health and science programs in 2009 is still up in the air.

When Congressional leaders returned from summer recess and the parties’ political conventions earlier this month, they faced a mountain of high-priority legislation to tackle in an ambitious three week work schedule set to end September 26th.  However, the legislative calendar has been thrown into flux as the focus on Capitol Hill turned this week to the nation’s financial crisis.  Debate on the Administration’s Wall Street bailout package has consumed both the House and Senate, complicating action on key issues including an economic stimulus package, energy legislation and the stalled FY 2009 budget process.

Congress passed a continuing resolution, or CR, to keep the government – including agencies charged with protecting the nation’ public health such as the CDC, FDA and NIH – running after the October 1 start of the new fiscal year.  The CR would provide temporary funding through March 6, 2009 for most federal programs at the current year’s level, instead of the anticipated increases for science and research programs Congress proposed earlier this year.  The CR was approved by the House on September 24 and in the Senate on September 27.

Exactly when Congress will adjourn is unknown.  While Members are eager to return to their home states to campaign, the Democratic leadership has indicated that they may be returning next week for a brief October session or will even reconvene for a lame-duck session after the November elections to finalize priority issues once the political forecast for 2009 is decided.

Health Care Outlook 2009

The shortened September work schedule has precluded much in the way of significant action on the health policy front this fall.  However, it is worth taking a look at recently introduced legislation as indicators of the health care priorities expected in January when the 111th Congress is convened.

Drug and food safety issues continue to be front and center on Capitol Hill.  Leaders in both parties have indicated their intent for comprehensive FDA overhaul legislation in early 2009.  In addition to numerous FDA hearings in both chambers, a significant number of FDA-related bills have been proposed recently, including the FDA Food Safety Modernization Act (S. 3385), introduced by a bipartisan group of Senate leaders right before the August recess.  Various drug and food safety measures have been proposed in the House as well, where the issue is of particular interest to Energy and Commerce Committee Chairman John Dingell (D-MI).  Continued Congressional oversight of the Agency’s progress in implementing the reforms laid out in the FDA Amendments Act, which was signed into law exactly a year ago on September 27, is also expected.

Health Information Technology is another hot issue.  House Ways and Means Committee Chairman Pete Stark (D-CA) has introduced the Health-e Information Technology Act of 2008 (H.R. 6898), which looks to promote nationwide adoption of electronic medical records.  While Health IT legislation in the both the House and Senate has been held up repeatedly by concerns around cost and privacy provisions, it is an area that is seen by many as a key component of affordable and innovative health care reform.

Regardless of whether an Obama or McCain Administration is sworn in, health care reform will be at the center of Congressional debate next year.  Health, Education, Labor and Pensions Committee Chairman Edward Kennedy (D-MA) is already moving on a major policy initiative to provide universal coverage.  Reportedly, his goal is to convene the key Senate committees to collectively create a single health reform measure.  Health IT, comparable health effectiveness research, enhanced chronic disease management programs and measures to strengthen Medicaid are likely to be components of this sweeping legislative package.

In addition, expect to see stem cell research, follow-on biologics, health privacy and the State Children’s Health Insurance Plan (SCHIP) as other top priorities of the health agenda.

 

 Groups Call for $200M in Federal Funding for HIV/AIDS Prevention

HIV/AIDS data indicates there are more new cases of Americans infected with HIV than previously believed. The Centers for Disease Control and Prevention (CDC) released new information in July, just in time for the International AIDS Conference.

The report stated that there are 56,300 new HIV infections in the United States (as of 2006). Compared to the 2004 report – which confirmed 40,000 cases – this new statistic is up 40 percent. The higher estimate is the result of more precise measurement methods, rather than a true increase in infection rates.

Earlier this month, a group of 70 HIV/AIDS advocacy and service organizations sent a letter to House Appropriations Chair David Obey (D-WI) and ranking member, James Walsh (R-NY) to ask for a $200 million increase in federal funding for prevention programs. In the letter, the groups argued that more federal funding is necessary to expand HIV prevention programs. CDC data reflected a decrease in new infections, from 130,000 in the late 1980s to 50,000 in the early 1990s. At the same time, CDC's budget increased by 50 percent.

"It is imperative that Congress respond immediately to alarming new incidence numbers and provide CDC additional funding to ramp up its prevention efforts," the letter said.

Audrey Spolarich, a Senior Advisor in Public Affairs and Health Policy at Spectrum, was an original member of the federal government team assembled at the National Institutes of Health (NIH) to address the HIV epidemic. 

Ms. Spolarich agrees that additional funds are needed for the CDC, as well as increased oversight for this and all federal government agencies that are funded to perform medical and scientific research. She also shared her thoughts about the NIH budget for AIDS research.

 “The 'un-doubling' of the NIH budget in all scientific areas is having an adverse effect on the speed and quality of AIDS and HIV research supported by the NIH. The old adage that 'one must always follow the money' continues to hold true for AIDS research funding. Just because the American public is suffering from a serious case of AIDS-fatigue does not mean we should give up on the millions of people affected by this disease,” said Ms. Spolarich.

 

 PhRMA HANDS OUT CODES

The Pharmaceutical Research and Manufacturers of America (PhRMA) recently announced a newly revised Code on Interactions with Healthcare Professionals. The updated Code, which is set to take effect in January 2009, builds on the principles set forth in the 2002 version.
The revisions are part of an ongoing effort to ensure that pharmaceutical marketing practices abide by ethical standards. The voluntary PhRMA code reaffirms that interactions between pharmaceutical company representatives and health care professionals should be focused on exchanging the most accurate educational information and the latest supporting medical research about prescription medicines.

PhRMA’s Web site reads, “This Code is to reinforce our intention that our interactions with health care professionals are professional exchanges designed to benefit patients and to enhance the practice of medicine.”

The revised code prohibits the distribution of non-educational items, such as pens and mugs imprinted with a company or product logo, to health care providers and their staffs. It also prohibits pharmaceutical sales representatives from purchasing restaurant meals for health care professionals and includes provisions that require company representatives to be educated about applicable laws, regulations and industry codes of practice. The Code addresses interactions between PhRMA representatives and health care professionals with respect to marketed products and pre-launch activities.

PhRMA will post on its Web site a list of those companies that have pledged to follow the Code, contact information for each company’s compliance officers and information about the companies’ annual certifications of compliance.

“We have heard the voices of policymakers, health care professionals and others telling us that we can do better,” said Billy Tauzin, President and CEO of PhRMA. The code “marks a renewed pledge to ‘practice what we preach.’ We hope all companies that interact with healthcare professionals will adopt these standards.”


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