2008-09 AMSA Legislative Agenda

2. Congress must act to guarantee affordable access to essential medicines and regulate the conflict of interest to increase professionalism in interactions between pharmaceutical industry representatives and prescribers.

Bioequivalent Background:

The cost of medicines is one of the most significant barriers to patient adherence to the treatments and medications that doctors prescribe. Many medicines to treat cancer, heart disease and other chronic conditions are biologics. Biologics are small molecule drugs made from living human or animal proteins. Approximately 25% of the new drugs slated for introduction to the global market are biologics. In 2006, biologics accounted for 15% of U.S. prescription drug sales. In 2007, global sales of biologics, at 12.5%, increased by nearly double the rate of growth in sales for traditional pharmaceuticals, at 6.7%. Biologics are exceptionally expensive; in 2006 the five top-selling biologics accounted for 30% of Medicare part B spending.

For future physicians interested in caring for underserved populations, every measure our legislators can take to decrease and control prices will increase our ability to provide access to necessary and life-saving medications for our future patients. Introducing generic competition is the most effective and important means to make medicines more affordable.

The 1984 Hatch-Waxman Act lays the framework of the six bills that Congress has introduced since 2007 to create approval pathways that decrease the cost of these medications through introducing competing, more affordable bioequivalent drugs.

AMSA Bioequivalent Position:

Congress must prioritize access to affordable essential medicines for patients over the profit of pharmaceutical companies. This can be achieved with passage of legislation setting policies such as those included within H.R. 1038, the Access to Life Saving Medicines Act of 2007. Introduced in the House on February 14, 2007 by Waxman-Emerson-Pallone-Emmanuel. The companion Senate Bill did not pass committee so we are in current need of companion legislation in the Senate.

A June 2008 Congressional Budget Office study on one subset of biologics estimates that passage and implementation of the policies in S.B.1695, Biologics Price Competition and Innovation Act of 2007, would save U.S. purchasers $25 Billion over 9 years.

1. Data Exclusivity – When a generic company seeks government approval to produce a generic version of a brand-name drug, the company relies upon existing data from tests conducted by the brand-name manufacturer. Proposed legislation that prevents use of this data by generic companies for lengthy periods of time will effectively lengthen the time a brand-name product enjoys an inappropriate monopoly of the market. Congress must pass biogenerics legislation that excludes provisions requiring data exclusivity.
   
   
2. Pathway to market approval – The FDA must be granted the flexibility to ensure case-by-case quality of biogenerics without imposition of needless administrative hurdles to approval.
   
   
3. Patent dispute resolution – Biogenerics legislation must not encourage frivolous, expensive lawsuits. Brand name companies must be required to disclose all related patents to the public so that potential generic companies have sufficient information on patented materials before embarking on production of biogenerics.

Conflict of Interest Background

The quality of care for many patient conditions depends on access to essential medicines and the existence of non-biased medical professional prescribing habits. Non-biased prescribing behaviors are predicated on a high level of transparency and professionalism in relationships between pharmaceutical companies and medical professionals.

Pharmaceutical Companies spend over $57.5 Billion dollars a year on all promotions 6, a figure which includes such items as meetings, detailing, samples, and funding for pharmaceutical representatives to market new prescription medications to physicians and health care providers. Per rep, per annum, PhRMA spends $150K on each primary care physician and $330K on each specialty physician in our country 7.

Internal PhRMA documents state that 1 minute of interaction between a sales representative interaction and a doctor results in a 16% prescribing change, while 3 minutes with a doctor results in a 52% prescribing change 8.

The present extent of contact between physicians and industry affects prescribing and professional behavior of physicians. Meetings with pharmaceutical reps were associated with an increase in physician requests to add that rep’s drugs to the hospital formulary, and with changes in prescribing practices 9.

An analysis of drug sample distribution by prescribers showed that most free samples went to patients of higher socioeconomic status instead of poor and uninsured patients; the free sample prescribing habits reported in this study suggest that free samples should be categorized as a marketing tool, rather than a safety net benefit to public health 10.

Pharmaceutical Research and Manufacturers of America (PhRMA) is an American lobby group for the research-based pharmaceutical industry.

The public is losing trust in the medical profession due to this conflict of interest, and the cost of such broad advertising campaigns is passed on to patients—and stockholders. As future physicians, it is the responsibility of medical students to preserve the integrity of the patient-physician relationship, and to improve community trust and respect for our profession.

AMSA Conflict of Interest Position

Congress must fight to maintain and protect the non-biased, evidence-based focus of a quality medical education, to ensure our medical system can provide quality, affordable patient care for everyone.

Congress must approach its responsibility to protect public health with a focus on safety and prevention, rather than a focus on legal system compensation for those affected by medical errors or accidents. Strengthening the FDA and training and encouraging physicians to use technology and pharmaceuticals appropriately will achieve this goal.

Congress must require gifts over $50USD from pharmaceutical companies and their representatives to prescribers to be reported in aggregate, along with consulting fees, speaker panel engagements, and other relationship exchanges. The existing $500 USD gift reporting limit in the Physician Payment Sunshine Act of 2008 [HR 5605] and [S2029] is a lenient limit and must be adjusted downward.

Congress and pharmaceutical regulatory bodies must set and enforce meaningful penalties for non-compliance with reporting and gift limit requirements.

Academic Detailing Background

Congress must eradicate conflicts of interest between physicians and pharmaceutical companies. Legislation to fund and support academic detailing provides an educational information alternative to marketing information.

Academic detailing provides prescribers with unbiased information, encouraging the use of the safest, most effective and – other things being equal – least costly drugs. Cost savings in this context means savings for patients, for public and private insurers and for taxpayers, whether or not they take medication 11.

Academic detailing has lowered health care costs without restricting services in other country systems 12. The costs of prescription drugs in the U.S. grew at more than 12% annually between 1990 and 2000, and despite a slower rate of price increase, national expenditures on prescription drugs still rose 6% from 2004 to 2005 13. We must invest in evidence-based continuing medical education practices shown to decrease costs.

Academic detailing programs educate prescribers through individual visits on unbiased information on the safety, effectiveness, and cost of prescription drug options.

AMSA Academic Detailing Position

To expose the impact that the quality of provider pharmaceutical knowledge has on patient care and health care costs, Congress must pass legislation supporting independent continuing medical education. This would be accomplished with the passage of the Independent Drug Education Act of 2008, or the IDEA Act.

Congress must support and fund programs such as academic detailing that are shown extensively to shift prescribing behavior away from inappropriate, expensive, heavily marketed drugs, toward generic, low-cost drugs.

Congress must fund development and production of non-biased educational materials on classes of pharmaceuticals, and provide for the regular updating of such materials. Such funding streams must recognize that industry-funded “educational materials” are inherently biased, and as such must not permit private or industry-funded organizations to be eligible to apply for or receive such grant monies.

6 Gagnon MA, Lexchin J The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. 2008 PLoS Med 5(1): e1 doi:10.1371/journal.pmed.0050001
7 Goldberg M and Davenport B. Pharm Exec. 2005 Jan 1;25(1): 70. Article from PhRMA Industry source.
8 Prounis C. Best foot forward. Communique, vol 7. Available at http://www.communiquelive.com/archive.cfm?ArticleID=622&back=-1&articleAccess=1.
9 Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000 Jan 19;283(3)373-80.
10 Cutrona et al. Characteristics of Recipients of Free Prescription Drug Samples: A Nationally Representative Analysis Am J Public Health. 2008;98:284–289. doi:10.2105/AJPH.2007.114249.
11 Testimony of Allan Coukell, BSc (Pharmacy), Director of Policy for The Prescription Project and Community Catalyst, before the Senate Special Committee on Aging, March 12, 2008
12 Ibid.
13 Kaiser Family Foundation Prescription Drug Cost Background Brief, accessed at http://www.kaiseredu.org/topics_im.asp?id=352&parentID=68&imID=1