What’s Happening in Washington
Trump Administration Unveils Plan for Revamped Medicare Drug Payments – The Trump Administration proposed a new Medicare payment model for certain prescription drugs that is certain to meet pushback from both doctors and the pharmaceutical industry. The plan would tie what Medicare pays for drugs administered at a doctor’s office under Part B to what other nations with advanced economies pay for those products. HHS expects to propose the rule during the spring of 2019 and could start a model in the spring of 2020. HHS projects the plan would save Medicare $17.2 billion over five years.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Discusses Diabetes Drug Safety Rules – FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met to discuss what kinds of studies it should require to determine whether diabetes drugs help the heart, or hurt it. The current FDA requirement, that companies first prove that a new medicine does not create excess harm for the heart and then conduct a study to see if the medicine prevents heart attacks and other heart problems, dates back to 2008 when a series of controversies about unsafe medicines made national headlines.
What We Are Working On
Trump Administration Plan to Define Gender Based on Anatomy at Birth – On October 21 the New York Times reported that the Trump Administration “is considering narrowly defining gender as a biological, immutable condition determined by genitalia at birth.” The proposed policy was leaked and available publicly. We immediately worked to get our experts and our position statement out. On October 23, the New York Times follow-up story on the transgender policy featured Endocrine Society member Josh Safer and noted the key points in our position statement. Society member Vafa Tabatabaie also published an op-ed in Time.
Trump Administration Proposal to Reverse ACA Rule Requiring Employers to Cover Birth Control – The Trump Administration is expected to issue proposed regulations that would expand religious and moral exemptions for covering birth control in employer health insurance plans, a move that critics say would limit women’s access to contraception. This change would most likely reverse a controversial mandate in the Affordable Care Act that required employers to cover birth control. The new regulations were filed last week for review with the Office of Management and Budget. We will continue to monitor and respond to the proposal with our position statement on contraception.
BPA Safety – On October 23 the Society conducted a virtual news conference to discuss the safety of BPA. Society members and EDC experts Laura Vandenberg, PhD and Heather Patisaul, PhD discussed and disagreed with the FDA’s current position on the safety of BPA. They noted that the FDA’s most recent literature analysis on BPA only considered a narrow view of existing research and was incomplete.
NIH Announcements
NIH Solicits Input on Initiatives
Two opportunities for Endocrine Society members to help NIH identify research priorities: please announcement of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Strategic Plan and the RFI NIH Blueprint for Neuroscience Research
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