September 19 Rally for Medical Research Hill Day – We were a proud sponsor of the Rally for Medical Research Hill Day. The Hill Day brought together over 300 research, patient, and medical organizations to advocate for increased funding for medical research.
What's Happening in Washington
NIH Funding Caught in Appropriations Drama as Senate Bill Would Provide $3 Billion Increase for NIH—With no final agreement in sight for appropriations, this week the House of Representatives passed a stopgap spending bill known as a “Continuing Resolution” that will continue government funding until November 21. The Senate is now expected to pass the Continuing Resolution next week before the September 30 deadline. The Continuing Resolution will give the House and Senate seven weeks to come to agreement on a final appropriations bill.
A stopgap measure is needed because none of the dozen regular spending bills have become law yet. First, Congressional leaders and the White House were not able to agree on topline fiscal 2020 funding caps until late July before heading home for the August recess. Then, the Senate Appropriations Committee did not start work on its own bills until last week and the Senate has had several standoffs over funding allocations and policy riders. The House passed 10 of its 12 bills, but at funding levels that were not agreed to by Republicans or the White House.
In an unexpected and unusual move as the Continuing Resolution began to advance, the Senate Appropriations Committee also released the text of its version of the Labor-HHS-Education appropriations bill, which funds the National Institutes of Health (NIH). The Senate bill would provide a $3 billion increase for the NIH, providing that agency with a $42.1 billion budget in fiscal year 2020. While the extra $3 billion for NIH would normally be an area of bipartisan agreement, the fact that other programs would see lower funding increases or even decreases as a result also could be a point of tension. House Democrats proposed raising NIH funding by $2 billion, and also provided the CDC with a nearly $1 billion increase — while the Senate is proposing around a $200 million increase compared to the agency's $7.3 billion fiscal 2019 level.
There will be a lot to reconcile between the two chambers on both spending levels and policy provisions. The House bill is filled with language that would overturn Trump administration policies, including the federal family planning funding rule that Senate Democrats would like a chance to overturn. The House bill would provide $400 million for that program, known as Title X, while the Senate version would provide $286 million, keeping it flat with current funding.
It is critical that Congress hear that we need it to complete action on fiscal year 2020 appropriations in a timely and bipartisan manner and that we urge it to provide at least a $2 billion increase for the NIH. If you have not done so, please take a minute to participate in our online advocacy campaign.
It is critical that all members of Congress hear from YOU about why these issues are important!
Special Diabetes Program Gets Seven Week Renewal in Continuing Resolution–One of our top legislative priorities is to renew funding for the Special Diabetes Program (SDP). The program, which……
is scheduled to expire September 30 unless Congress acts. Because Congress understands the importance of SDP, the program has been included in the Continuing Resolution, but the CR will only extend funding through November 21. We will bring Endocrine Society members to Washington, DC September 23 to advocate for a long-term extension of the SDP. Even if you are not joining us in Washington, you can help by taking action using our online advocacy campaign.
Speaker Pelosi Unveils Drug Pricing Legislation—Speaker of the House Nancy Pelosi (D-CA) unveiled drug price negotiation legislation she has been working on. We are pleased to see that insulin is specifically mentioned and highlighted in the proposal. The proposal would require Medicare to negotiate with drugmakers on the price of certain prescription drugs. The main provisions of the proposal are summarized below:
Secretary identifies 250 brand-name drugs each year that lack price competition and are the greatest cost to Medicare and the US health system
A drug would qualify if it is a brand-name drug that does not have a generic or biosimilar competitor
Insulin is specifically mentioned as a drug that would be included for negotiation
Secretary must take into account which drugs would result in the greatest savings to the system
Requires negotiations on at least 25 drugs annually, up to 250
A drug selected would continue in the program until competition enters the market
Negotiations would be to reach a maximum fair price, with an upper limit for the price reached as no more than 1.2 times (or 120 percent) of the volume-weighted average of the price of six specifics countries (Average International Market (AIM) price)
If a manufacturer chooses not to participate in negotiation or withdraws, they will be assessed an escalating excise tax based on their annual gross sales (starting at 65 percent and increasing by 10 percent every quarter, to a maximum of 95 percent)
Once a price is negotiated, the manufacturer may not increase the price faster than inflation each subsequent year until competition enters the market
The maximum fair price would be applied to Medicare and must be offered to the commercial market as well.
To address the “unjustified” price hikes over the years, all of the 8000+ drugs in Medicare Part B and D would face an inflation rebate – if the price has increased above the rate of inflation since 2016, the manufacturer can lower the price or pay the entire price above inflation in a rebate back to the Treasury.
Creates an out-of-pocket maximum for Part D enrollees. Annual OOP limit will be set at $2000 (catastrophic phase is currently reached at $5100) – there will be no additional cost share required above this maximum.
Savings from the new system will be reinvested in the Medicare program and directed to the NIH to continue innovation on new medications.
Chances of passage of the proposal are unclear. Most, if not all, Republicans would likely vote against the bill – they are already expressing their displeasure that the bill was drafted behind closed doors and without Republican input (and because they generally do not support government regulation of price). It does include some elements that the President has endorsed in the past (international price index), however. If the President were to support the bill, this may give some Republicans cover to vote for it. We will continue to monitor and will provide additional details as they become available.
Endocrine Society Launches Online Advocacy Campaign for our European Members—The European Commission has begun to take steps towards developing a comprehensive chemical regulation strategy, but additional pressure is needed to ensure that it follows through on this important effort. With the election of a new European Parliament, we have an opportunity to raise the profile of endocrine-disrupting chemicals (EDCs) and ensure that the Parliament prioritizes this issue throughout their 5-year term from 2019-2024. We have launched an online advocacy campaign for our European members to contact Members of the European Parliament on our “take action” webpage.
Our Latest Policy Communications
Coalition Letter on Special Diabetes Reauthorization
We joined a coalition of organizations urging House and Senate leaders to renew the Special Diabetes Program
Coalition Fetal Tissue Research Letter
We joined a coalition of organizations calling on the NIH to eliminate or modify procedures described in new NIH policies on research using fetal tissue to protect the scientific peer-review process, ease compliance, and clarify the new requirements.