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.


Pick for FDA faces Senate committee

April 6, 2017
Scott Gottlieb, MD ― President Trump’s pick for commissioner of the U.S. Food and Drug Administration (FDA) ― faced the Senate Health, Education, Labor, and Pensions Committee at a confirmation hearing this week and discussed his thoughts about the drug-approval process. Specifically, Dr. Gottlieb indicated that the current process slows down the rate of drug approvals and can be improved without sacrificing safety. Dr. Gottlieb also stated that his first priority as commissioner of the FDA would be to address the U.S. opioid epidemic.

During the hearing, Dr. Gottlieb also answered questions about his financial and advisory ties ― which were listed in Dr. Gottlieb’s conflict of interest notice ― with about 30 medical companies. Dr. Gottlieb indicated that he would work “…with the ethics officials at HHS and FDA to have continued discussions on what additional steps I should take to make sure I’m fully complying with the law if I’m confirmed into this role.”

Dr. Gottlieb, an internist, served as deputy commissioner of the FDA under President George W. Bush. The Committee is expected to vote on Dr. Gottlieb’s appointment after congressional recess.


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.


White House picks lead for FDA

March 10, 2017
President Trump has nominated Scott Gottlieb, MD, to lead the U.S. Food and Drug Administration (FDA).  In the past, Dr. Gottlieb has stated that administrative red tape is preventing competition in the drug manufacturing industry, and if confirmed, he would likely have an integral role in President Trump’s efforts to speed up the drug-approval process.

Dr. Gottlieb has a medical degree from Mount Sinai School of Medicine and did his residency in internal medicine at the Mount Sinai Medical Center. Dr. Gottlieb previously served as a deputy commissioner of the FDA under President George W. Bush.


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.


Senate Committee approves Dr. Price

Feb. 1, 2017
The Senate Finance Committee has approved the nomination of Tom Price, MD, to serve as secretary of HHS. Dr. Price's nomination will now go to the full Senate for a vote.

A vote on Dr. Price's approval was delayed yesterday in the Senate Finance Committee after committee Democrats boycotted the vote. The Committee rules require that at least one Democratic member must be present for the Committee to proceed. However, today Committee Republicans agreed by unanimous consent to temporarily change the committee’s rules, thereby allowing the committee to vote in favor of approving Dr. Price.


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.


What’s next for compounding?

Dec. 19, 2016
The American Academy of Dermatology Association (AADA) recently joined 16 organizations representing physicians, patient advocates, pharmacists and other health care providers in sending a letter to the transition team of President-elect Donald Trump regarding patients’ access to compounded medications. This comes as the U.S. Food and Drug Administration (FDA) considers finalizing compounding guidance documents which could limit compounding where the drug is considered a copy of a drug that is commercially available.

The letter expresses concern about the FDA’s implementation of the Drug Quality and Security Act (DQSA). It reads: “During a time of rising drug prices and increasing shortages, it is paramount that patient access be preserved for compounded medications. We are concerned that the FDA is implementing the DQSA in a way that is negatively impacting patient access to medications and subjecting state-licensed compounding pharmacies to FDA oversight and manufacturer standards in a way that exceeds the authority given to the Agency by Congress.”

In addition to asking that the new Administration consider rescinding these guidance documents, should the FDA proceed with finalizing them, the letter also offers ongoing assistance on these important issues to the transition team and the Trump Administration’s still-forming health policy team.

It is not clear where President-elect Trump stands on the FDA’s draft compounding guidance. Click here to read more about the guidance documents and learn how you can voice opposition to these restrictions.


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.


President-elect Trump picks Dr. Price for HHS

Nov. 30, 2016
President-elect Donald Trump has nominated House Budget Committee Chair, Rep. Tom Price, MD (R-Ga.), to serve as Secretary of the U.S. Department of Health and Human Services.

Dr. Price, an orthopedic surgeon, has been a staunch supporter of the full repeal of the Affordable Care Act (ACA) ― he introduced the Empowering Patients First Act in 2015 which would fully repeal and replace the ACA with a system that includes individual health pools and expanded health savings accounts, and would have given physician groups control over performance-based quality measures. As a physician, Dr. Price has indicated that he understands the administrative burdens placed on the physician community and has expressed concerns over the burdens of electronic health records and Meaningful Use ― indeed, he was instrumental in the passage of a blanket hardship exemption from MU requirements in 2015. He also supports allowing physicians to balance bill their Medicare patients, repealing the Independent Payment Advisory Board (IPAB), allowing the use of in-office compounded drugs, preserving the In-Office Ancillary Services Exception to the Stark Law, and ensuring that step therapy protocols do not impede patient access to necessary treatment. 

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.

President-elect Trump’s nominations will require a simple majority vote in the Senate. Hearings on his nominations will likely take place in early January. The AMA and other medical organizations have announced their strong support for Dr. Price's nomination.