[Ip-health] Fwd: White House and Congress Must Address Drug Pricing and Access to Critical HIV, HCV, and TB Medications

Suraj Madoori suraj.madoori at treatmentactiongroup.org
Tue Jul 17 06:01:11 PDT 2018

*Apologies for cross-posting and duplicates*


White House and Congress Must Boldly Address Drug Pricing and Ensure Access
to Critical HIV, HCV, and TB Medications​
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
   - *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.

*Suraj Madoori*
U.S. and Global Health Policy Director
*Treatment Action Group*
mobile: +1.917.530.5996

*Treatment Action Group *
90 Broad St, Suite 2503
New York, NY 10004 USA
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