AAM Provides Comments in Response to Administration’s Blueprint on Drug Pricing

Generic and Biosimilars Competition Drives Lower Prices and Reduced Out-of-Pocket Costs for Patients

Washington DC (July 16, 2018)—The Association for Accessible Medicines (AAM) and the Biosimilars Council have today filed comments on the Trump Administration’s drug pricing blueprint. The Blueprint identifies four overarching goals for lowering drug prices: increasing competition; better negotiation; creating incentives for lower list prices; and reducing patient out-of-pocket spending.

“Enhancing patient access to generic and biosimilar medicines is foundational to each of these – providing competition and reducing patient out-of-pocket, as well as overall system, costs through significantly lower list prices that decline further over time,” says AAM President and CEO Chip Davis. “Simply put, generic and biosimilar medicines make health care more accessible and affordable for all of America’s patients.”

AAM and the Council recommend the following five actions for HHS to achieve its goals for patients, detailed in our comments:

  1. Re-examine the role of rebates.
  2. Prevent the misuse of restricted access programs to block generic and biosimilar competition.
  3. Protect incentives for generic competition.
  4. Foster the development of a robust competitive U.S. biosimilars market.
  5. Combat patent abuse.

AAM and the Council appreciate the Administration’s leadership and approach in issuing American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. We applaud and share the Department’s interest in supporting a health care system that provides high-quality care at affordable prices for the American people. This is the core mission of the generics and biosimilar medicines industry.

“It is sobering to consider what America’s patients would face if there were no FDA-approved generic or biosimilar medicines to provide reliable access to affordable treatments. Generics do not merely deliver the most medicine at the lowest cost and greatest savings. Every day, generics cushion the significant financial impact of high brand name drug prices for patients and the health care system,” Davis noted.

While prices for FDA-approved generic medicines are currently declining by more than 7 percent year over year, prices for brand drugs, especially biologics and specialty medicines, are increasing at an unsustainable rate – 62 percent from 20111 to 2015. FDA and HHS officials have recently acknowledged that generic medicines may be underpriced and that paying too little for them may have negative consequences2. Accordingly, HHS should work to not only help generics and biosimilars come to market, but should also take steps to ensure that they are able to stay on the market.

View AAM Comments


ATTRIBUTE TO: Allen Goldberg, AAM Vice President, Communications


Allen Goldberg
202.249.7110 (o)
202.251.8881 (c)


Morgan Stanley. June 29, 2018. “Spec/Gx Trends in Pictures”.
U.S. Department of Health and Human Services Office of Inspector General. June 2018. Data Brief: Increases in Reimbursement for Brand-Name Drugs in Part D Senate Finance Committee Full Committee Hearing on Prescription Drug Affordability and Innovation: Addressing Challenges in Today’s Market. June 26, 2018.



About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. 

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

Association for Accessible Medicines


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