Advocacy in Action: FDA Plan to Improve Efficiency of Product Development, EPA Transparency, and More

  • Jul 2018

Here’s a summary of the latest advocacy issues the Endocrine Society is working on.

What’s Happening in Washington:

There is a growing attention among policymakers to the issue of prescription drug prices:

  • FDA has announced a “Biosimilar Action Plan” outlining how to improve efficiency and scientific and regulatory clarity for product development, increase communications to expand use of biosimilars, and support market competition by reducing gaming.  Read the plan here
  • Prescription Drug Importation Workgroup Established
    Health and Human Services Secretary Alex Azar requested that FDA Commissioner Scott Gottlieb establish a working group to examine how to safely import prescription drugs from other countries in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities.  Read the HHS press release here and FDA Commissioner Gottlieb’s statement here.
  • The Senate Health Committee has announced mark up of legislation to lower spending on prescription drugs. This is the first step Congress will take on drug pricing since the Trump administration released its blueprint on the issue in May, the Senate Health, Education, Labor and Pensions Committee will mark up a measure (S 2554) sponsored by Senator Susan Collins (R-ME) on July 25 that would prohibit any health insurer offering plans on the exchanges set up under the 2010 health care law from blocking a pharmacist from telling patients if a prescription drug would be more affordable if they paid with cash rather than through their insurance.
  • Lilly has announced a new Insulin Helpline. Starting August 1, 2018 a new dedicated helpline called the Lilly Diabetes Solution Center, will assist people who need help paying for their insulin, such as those with lower incomes, the uninsured, and people in the deductible phase of their high-deductible insurance plans. people find solutions that best fit their personal circumstances. Helpline operators will guide people through a suite of solutions for all Lilly insulins including Humalog® (insulin lispro).
  • Dan Best, Senior Advisor to the Secretary for Drug Pricing Reform authored an article arguing that HHS has responded to the call to lower drug prices and is implementing changes.  He states, “The weeks and months to come will be a wakeup call for anyone who still doubts President Trump’s ability to fix a broken system and get better deals for the American people.” Stay tuned…

What We Are Working On:

EPA Transparency Rule

We joined with 68 other national health and scientific organizations to oppose EPA’s proposal to restrict the science it uses.  See our joint press release.

Global EDC Advocacy

We submitted comments to the European Commission encouraging the development of a comprehensive EU EDC Strategy

Medicare Physician Payment

The Centers for Medicare & Medicaid Services released proposed rules for the 2019 Physician Fee Schedule and the Quality Payment Program last week.  With 1,500 pages to review, this is not exactly light summer reading.  We are working with the Clinical Affairs Core Committee and Quality Improvement Subcommittee to carefully review the proposed changes and will provide additional information on the proposals in the weeks ahead, in addition to submitting comments on the proposals due on September 10. Of key interest and concern are proposed changes for E&M codes that could mean payment cuts for endocrinologists.

To find out how you can become more involved in endocrine advocacy, please contact [email protected].

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