Why FDA Should Implement Some of the National Academies’ Recommendations for Making Medicines Affordable

As the National Academies of Sciences, Engineering, and Medicine points out in a recent report, Making Medicines Affordable: A National Imperative, the U.S. biopharmaceutical sector has been successful in developing and delivering effective drugs for improving health and fighting disease over the past decades.  Many medical conditions that were long deemed untreatable can now be cured or managed effectively.  At the same time, spending on prescription drugs has been rising dramatically, to the point that many individuals have difficulty paying for the drugs that they or their family members need and drug costs are now a significant part of the nation's total spending on health care.

The National Academies report recommends a number of actions aimed at improving the affordability of prescription drugs without discouraging continued innovation in drug development.  These recommendations identify some of the key reasons why medications are both high cost and highly profitable.

Two of the recommendations are particularly important for their potential to both reduce the cost of prescription drugs and also improve the quality of health care.   These recommendations include implementing key strategies that would promote rational prescribing by providers. First, we need to limit or discourage direct-to-consumer advertising (Recommendation D) and secondly, restrict pharmaceutical visits by sales representatives and any financial incentives to prescribers (Recommendation H).

Some of the National Academies’ findings and recommendations dovetail with those of a recent study published in PLoS ONE on payments to Medicare providers in Washington, D.C., for which I served as one of the senior authors.  Our study involved researchers from both Georgetown University Medical Center (GUMC) and George Washington University’s Milken Institute School of Public Health.

We found that physicians and other health care providers who received “gifts” from pharmaceutical companies were much more likely to prescribe a higher number of drugs per patient, including more costly prescriptions for branded medicines, compared to prescriptions written by medical providers who did not accept gifts.  

Our analysis showed that gifts of any size had an effect on prescribing, and larger gifts elicited a larger impact. These gifts varied in value from as little as $7 a year (i.e. a dozen doughnuts), to as much as $200,000 in cash.

Our finding that gifts from pharmaceutical companies result in more prescriptions per patient is particularly concerning, because the more medications a patient takes, the higher the risk of adverse effects.

The National Academies’ D and H recommendations are particularly important because no national laws prohibit the acceptance of gifts or payments from industry to health care providers.

As my coauthor on the PLoS ONE paper, Adriane Fugh-Berman, MD, professor in the department of pharmacology and physiology at GUMC, puts it: “Every slice of pizza given to a physician compromises patient health.” This new NAM report makes clear recommendations, that if put into place, can make a difference to lower health care costs — the goal of the study — but with the additional benefit of helping assure that patients get better care.

Susan F Wood is Professor of Health Policy and Management, and of Environmental and Occupational Health. She is also the Director of the Jacobs Institute of Women's Health.  She served as the FDA’s Assistant Commissioner for Women's Health and Director of the FDA Office of Women's Health from 2000 until 2005.  She currently directs the AccessRX and DCRX projects which evaluates the role of pharmaceutical marketing in DC, and develops industry-free continuing health professional education on behalf of the DC Department of Health.

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