Federal Policy

The following are a few key federal bills relevant to PharmFree issues that have been intorduced in 2008 and will likely reemerge in 2009.

The Physician Payments Sunshine Act
The Independent Drug Education and Outreach Act
Comparative Effectivenesss Research Act of 2008

The TRADE Act of 2008
Access to Life Saving Medicines Act of 2007

 

The Physician Payments Sunshine Act (S.2029 and H.R.5605)

Sponsors: Mr. Grassley (R-IA) and Mr. Kohl (D-WI) in the Senate, and Mr. DeFazio (D-OR) and Mr. Stark (D-CA) in the House.

What is it?
Senate and House bills introduced in September 2007 and March 2008 respectively would require drug and medical device manufacturers to report all gifts and payments over the amount of $25 given to physicians. The information would be registered in a national and publicly accessible online database. This bill is very likely to be reintroduced in the 2009 session, possibly as part of larger health care reform legislation. 

Why is it needed?
Although disclosure will not end inapprorpiate relationships, it is a first and important step to understanding the nature and extent of Industry's financial interest in the medical profession. A penalty of at least $10,000 would be assigned to companies that fail to disclose.

For more detail, see the Prescription Project Fact Sheet: The Physician Payments Sunshine Act.

Link to bills: S.2029; H.R.5605

 

The Independent Drug Education and Outreach Act (IDEA) (S.3396 and H.R.6752)

Sponsors: Mr. Kohl (D-WI), Mr. Durbin (D-IL), Mr. Kennedy (D-MA) and Mr. Casey(D-PA) in the Senate, and Mr. Waxman (D-CA) and Mr. Pallone (D-NJ) in the House

What is it?
Companion bills intorduced in both the Senate (S.3396) and the House (H.R.6752) would create federally funded programs to send trained pharmacists, nurses, and other health care professionals into doctors' offices with independent data about the benefits, hazards, costs, and comparative effectiveness of the full array of pharmaceutical options for patient treatment, including low cost generic alternatives.

Why is it needed?
Practicing physicians currently get much of their information about drugs from pharmaceutical sales representatives, who have a vested interest in selling new, high-cost products. To ensure quality of care and to control soaring drug costs, it is essential that prescribing decisions be based on balanced, unbiased scientific information.

For more detail, see the Prescription Project Fact Sheet: The Independent Drug Education and Outreach Act
And the Prescription Project Fact Sheet on Academic Detailing

Link to bills: S.3396; H.R.6752 

 

Comparative Effectivenesss Research Act of 2008 (S.3408)

Sponsors: Mr. Baucus (D-MT) and Mr. Conrad (D-ND) in the Senate

What is it?
The Comparative Effectivenenss Research Act would establish a private non-profit research institute to review evidence and produce new information on how disseases, disorders, and other health conditions can be treated to achieve the best clinical outcome for patients. The institute would be funded through a trust by contributions from both public and private payers.

Why is it needed?
Comparative effectiveness is central to issues of both cost and quality. Optimal use of prescription drugs is hindered by a dearth of good head-to-head comparisons of new and existing therapies. FDA approval rests on a determination of superiority to placebo, giving companies little incentive to conduct comparative trials. Public policy related to comparative effectiveness research and evidence-based medicine (EBM) takes place against a background of a great deal of public misunderstanding of the terms - some of it deliberately induced by the pharmaceutical industry. We now see another important new trend in health, "personalized medicine" being held up as a polar opposite to EBM. It is not; both are important developments, and both raise important questions about distribution of limited health care resources.

Link to bill: S.3408

 

Trade Reform, Accountability, Development, and Employment Act of 2008 (S.3083)

Sponsors: Mr. Brown (D-OH), Mr. Casey (D-PA), Mr. Dorgan (D-ND), Mr. Feingold (D-WI), Mr. Whitehouse (D-RI) in the Senate

What is it?
The TRADE Act requires a review of existing trade pacts, including the North American Free Trade Agreement (NAFTA), the World Trade Organization (WTO) and other major pacts, and sets forth what must and must not be included in future trade pacts. It also provides for the renegotiation of existing trade agreements and describes the key elements of a new trade negotiating and approval mechanism to replace Fast Track that would enhance Congress' role in the formative aspects of agreements and promote future deals that could enjoy broad support among the American public.

Why is it needed?

 

U.S. policy should protect doctors' abilities to prescribe affordable medications to patients in need of treatment both domestically and abroad. We are concerned that some existing U.S. trade policies protect the ability of pharmaceutical companies to maximize profit, without regard to the negative role that expensive drug prices play in patient access to essential medicines.

Link to bill: S.3083

 


Access to Life Saving Medicines Act of 2007 (H.R. 1038)

Sponsors: Mr. Waxman (D-CA), Mr. Emerson (D-MO), Mr. Hirono (D-HI), Mr. Pallone (D-NJ), Mr. Stark (D-CA) in the House  

What is it?
Establishes a process through which the FDA will be able to approve lower cost copies of biotech drugs, also known as biologics or biopharmaceuticals.

 

Why is it needed?

Generic drugs (first made possible under the 1984 Hatch-Waxman Amendments) have been extremely successful in bringing down the high cost of prescription drugs. Generic drugs save patients and payers $10 billion a year. But there is no generic competition for one of the fastest growing and most expensive category of drugs: so-called biotech drugs, also known as biological drugs or biopharmaceuticals. It is common for these drugs to cost tens of thousands of dollars a year, even after patent expiration. Many patients are now denied access to these important drugs because even the co-payments can reach thousands of dollars a year. And the sky-rocketing cost of biotech medicines is imposing increasing burdens on employers, insurers, and the federal government. Introducing fair competition for biotech drugs is essential to keep these life-saving treatments affordable.

Link to bill: H.R. 1038