July 16, 2018 – Treatment Action Group (TAG), NASTAD (National Alliance of State & Territorial AIDS Directors) and HIVMA (HIV Medicine Association) join together in submitting collaborative comments today in response to the Department of Health and Human Services (HHS) public request for information (RFI) on the agency’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Our comments call on Congress and the White House to boldly address a broken drug pricing system and to hold the pharmaceutical industry accountable for its role in ensuring that critical disease-preventing and life-saving medications are both available and affordable, particularly for people living with HIV, hepatitis C (HCV), and tuberculosis (TB).
Click here to download the .pdf of the RFI response submitted to the Department of Health and Human Services.
There is increasing bipartisan support for prescription drug cost controls and a groundswell of community advocacy for novel, forward-thinking statutes and regulations that appropriately balance access and cost. The fact is, egregious drug pricing hurts the health of American residents and has been a barrier to the latest HIV, HCV, and TB prevention and treatment innovations in recent years.
The HHS Blueprint released in early May 2018 is one of the most proactive drug pricing plans produced by a White House administration. Though it includes many more exploratory questions than it does meaningful policy recommendations, it rightly notes that high medicine prices and unsustainable spending on pharmaceuticals and biologics are rooted in problems at virtually all points in the complex U.S. pharmaceutical market. This is in part due to existing federal laws and regulations that have either never been applied or haven’t kept pace with largely successful pharmaceutical industry efforts to game existing controls.
Largely missing from the HHS Blueprint are exploratory questions and concrete policy strategies challenging pricing practices by the pharmaceutical industry itself, including: 1) unjustified launch prices, particularly those beyond what the market can reasonably bear, resulting in inequitable access to lifesaving therapies; 2) net and list price increases that are out of lockstep with rates of inflation; 3) monopolization of critical generic drug products, notably those for serious but low-prevalence diseases that do not constitute large market shares; and 4) the use of anti-competitive tactics among brand-name drug and biologic manufacturers to prevent timely generic competition, including patent thickets, evergreening, and REMS abuses.
In this response, we examine aspects of the HHS Blueprint that are most crucial to drug and biologics pricing and access in HIV, HCV, and TB, in the context of the following recommendations:
- Curtail “Global Freeloading” Rhetoric and Related Policy Threats
- Recalibrate FDA Regulations to Maximize Competition and Ensure Stringency
- Modernize Inflationary Rebate Limits
- Evaluate and Implement Drug Pricing Transparency
- Deter Cost Sharing under Part D and other Commercial Plans
- Protect AIDS Drug Assistance Programs Under 340B
- Centralize Purchasing and Price Negotiations
- Recognize and Invoke Eminent Domain/March-in Rights
TAG is doubling down on its commitment to advocacy challenging public policy and industry practices that fail to adequately address drug pricing as a significant barrier to safe and effective prevention and treatment of HIV, HCV, and TB in the United States. With submission of these comments in response to the HHS Blueprint and with careful attention to resulting regulations or legislation, we aim to ensure that the Administration and Congress use their authority to prioritize swift and meaningful policy action against runaway drug pricing to the betterment of people living with and vulnerable to HIV, HCV, and TB and American society as a whole.