DW blog: The First 100 Days

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Trump pick for FDA confirmed

May 10, 2017
Scott Gottlieb, MD, has been confirmed by the U.S. Senate to serve as the commissioner of the U.S. Food and Drug Administration. The Senate voted 57-42 in favor of confirmation. Dr. Gottlieb, an internist, served as deputy commissioner of the FDA under President George W. Bush.


Pick for FDA moves forward

April 27, 2017

The Senate HELP Committee has voted 14-9 to advance Scott Gottlieb, MD ― President Trump’s nomination for commissioner of the U.S. Food and Drug Administration (FDA).

Dr. Gottlieb, an internist, served as deputy commissioner of the FDA under President George W. Bush. The full Senate will now vote on Dr. Gottlieb’s nomination. However, a date has not been set for the vote yet.


White House budget proposes cuts to NIH, HHS

March 17, 2017
President Trump’s proposed $1.1 trillion budget for fiscal year 2018 calls for an increase in spending for the departments of Defense, Homeland Security, and Veterans Affairs. However, President Trump proposes to cut funding for the National Institutes of Health by $5.8 billion and the Department of Health and Human Services by $15 billion ― which, if finalized could affect biomedical research and cancer research efforts established by the 21st Century Cures Act.

The Administration’s proposed budget is a blueprint for Congress to work off of when establishing the fiscal year 2018 federal budget.


President Trump picks HHS deputy secretary

March 15, 2017
President Trump has announced his intent to nominate Eric D. Hargan, JD, to serve as deputy secretary of the U.S. Department of Health and Human Services (HHS). Hargan is a shareholder of Greenberg Traurig, LLP, in its Health and FDA Business practice. He previously served as deputy general counsel, principal associate deputy secretary, and acting deputy secretary of HHS under the George W. Bush Administration. Hargan’s nomination will require a Senate confirmation.


Senate confirms Tom Price for HHS Secretary

Feb. 10, 2017
The U.S. Senate has voted (52-47) to confirm Dr. Tom Price as Secretary of the U.S. Department of Health and Human Services (HHS) under President Donald Trump. Dr. Price, an orthopedic surgeon, previously served as congressman for Georgia’s 6th district and as House Budget Committee chair and would be the first physician to serve as secretary of HHS in nearly 25 years. Dr. Price has worked on issues affecting dermatology, such as Medicare payment reform, shortening EHR reporting periods, and ensuring that the MACRA transition included opportunities for physicians to avoid penalties. Dr. Price has also demonstrated a commitment to decreasing over-burdensome regulations associated with EHR, MACRA, and quality reporting.

In other confirmation news, the Senate Finance Committee will hold a confirmation hearing for Seema Verma, President Trump's pick for CMS administrator, next week.


NIH director to stay put

Jan. 20, 2017
Francis Collins, MD, PhD, will remain as the director of the National Institutes of Health (NIH) under the Trump Administration. However, it is unclear if Dr. Collins will remain in the position permanently. About 50 Obama appointees will remain under the Trump Administration to maintain continuity until President-elect Trump’s nominees are confirmed. Dr. Collins is a is a physician-geneticist and has served as the director of the NIH since 2009. He has garnered bipartisan support in Congress.


Tentative hearing scheduled for Dr. Price nomination

Jan. 3, 2017
The Senate Health, Education, Labor and Pensions Committee has set a tentative date for a hearing for Rep. Tom Price, MD (R-Ga.) ― President-elect Donald Trump’s pick for Secretary of the U.S. Department of Health and Human Services ― on Jan. 18. However, the hearing date will not be officially announced until one week before it is definitively scheduled to occur. This is would be a courtesy hearing, as it is the Senate Finance Committee that will ultimately vote on the nomination.

The American Academy of Dermatology Association (AADA) has had a long-standing relationship with Dr. Price, who was a featured speaker at the AADA's 2012 Legislative Conference. The AADA has worked with him on issues such as Medicare payment reform, shortening EHR reporting periods, and ensuring that the MACRA transition included opportunities for physicians to avoid penalties.

Similarly, Seema Verma, President-elect Trump’s choice for CMS administrator, can anticipate a confirmation hearing in the near future. Although a date for her hearing has not been publicly floated, the Senate Finance Committee indicates that it has received three years of tax returns and completed questionnaires from both Dr. Price and Verma.


Cures, drug pricing, and the next Administration

Dec. 14, 2016
Yesterday afternoon at the White House, joined by Vice President Joe Biden and key lawmakers from both parties, President Obama signed into law the 21st Century Cures Act, which makes new advancements in medical research and seeks to accelerate the approval of new drugs and treatments for patients. “It is wonderful to see how well Democrats and Republicans in the closing days of this Congress came together around a common cause,” said the President at the official signing ceremony. “I think it indicates the power of this issue and how deeply it touches every family across America.”

Among the federal agencies tasked with implementing the 21st Century Cures Act is the National Institutes of Health (NIH), which will see an increase in funding. Francis Collins, MD, PhD, a physician-geneticist, currently heads up the medical research agency. While President-elect Trump has yet to announce his picks of whom he wants to lead the Food and Drug Administration and the NIH, several key Republicans have expressed their support for keeping Collins on board.

The 21st Century Cures Act was applauded by many as it made its way through Congress and to the President’s desk for signature. However, additional actions are expected in the coming months in order to help address escalating drug prices. Barbara Greenan, senior director of Advocacy and Policy at the AADA, said the AADA “…looks forward to working with the new Administration and Congress on addressing this highly impactful issue in the context of other health system reforms.”


Tackling drug prices

Dec. 7, 2016

Congress has passed the 21st Century Cures Act, legislation that will provide funding for the U.S. Food and Drug Administration (FDA) to accelerate the drug and medical device approval process. The legislation will also provide funding for basic, translational, and clinical research. The legislation is deemed by many as a means to quell the rising cost of drugs by encouraging more drugs to enter the market more quickly. However, additional efforts to address this issue are likely when the new Administration and Congress take over, and according to Barbara Greenan, senior director of Advocacy and Policy at the AADA, they will be multifaceted. “Certainly, expediting the backlog of generic drug approvals at the FDA is one way to drive down drug prices. However, this issue is complex and the new Congress and Administration will have to work with all stakeholders to find solutions that ensure patients have access to effective treatments.”

Specifically, several members of Congress are looking to alleviate the drug pricing issue by granting Medicare the authority to negotiate drug prices with manufacturers. “This is a concept that Democrats have largely supported and that President-elect Trump supported while on the campaign trail, but congressional Republicans generally oppose it,” said Christine O’Connor, AADA associate director of congressional policy.

Another option that has been kicked around is removing restrictions on drug importation. For example, in the 114th Congress, Sens. John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.) introduced the Safe and Affordable Drugs from Canada Act. “President-elect Trump has indicated that he would support re-importation of drugs,” O’Connor said, “and there is some bipartisan support in Congress to do this. However, the pharmaceutical industry opposes re-importation.” Similarly, Congress may also turn the focus on the manufacturers and require more transparency into drug-pricing methods. “For example, in the 114th Congress, Sens. John McCain (R-Ariz.) and Tammy Baldwin (D-Wis.) introduced the FAIR Drug Pricing Act that would require drug manufacturers to explain price increases of more than 10 percent.” While these pieces of legislation will die at the close of the 114th Congress, similar legislation may be introduced next year in the new 115th Congress.

Of course, even if legislation passes muster in both chambers on the Hill and in the White House, the new Administration will likely be tasked with implementing these new laws. “There will be a heavy lift on the regulatory side to implement and operationalize drug pricing legislation,” Greenan said. “However, rising cost of drugs cannot be ignored and the AADA looks forward to working with the new Administration and Congress on addressing this highly impactful issue in the context of other health system reforms.”


Congress appoints new E&C chair

Dec. 1, 2016
While President-elect Donald Trump’s transition team is vetting members of the new Administration’s cabinet, on Capitol Hill, Rep. Greg Walden (R-Ore.) has been selected as the chair of the U.S. House Energy and Commerce Committee which has jurisdiction over issues concerning health care, and is the primary committee for addressing the Affordable Care Act, the Medicare Access and Chip Reauthorization Act (MACRA), compounding, drug pricing, and the 21st Century Cures bill that, if passed, would provide medical research funding. Rep. Walden will replace Rep. Fred Upton (R-Mich.), who has served in the role since 2010. Rep. Walden is the outgoing National Republican Congressional Committee chairman. According to his congressional website, he is in favor of repealing and replacing the Affordable Care Act and he also supported the 21st Century Cures Act.