POLICY BRIEFINGS


HHS Personnel Departures


Chief Medical Officer at the Centers for Medicare and Medicaid Services (CMS) Kate Goodrich has announced that she will be leaving the agency next month. Dr. Goodrich also serves as the Director of the Center for Clinical Standards and Quality, and she has led the Quality Measurement and Value-Based Incentives Group since 2012. During her time at CMS, Dr. Goodrich has been responsible for quality measurement and improvement, public reporting work, the marketplace quality portfolio, value-based incentives programs, implementation of the Medicare Access and CHIP Reauthorization Act (MACRA), and comparative effectiveness research. She plans to join Humana Corp. as the company’s next senior vice president, overseeing the insurer’s data, trend, and analysis work. Jean Moody-Williams will serve as acting head of the CMS clinical and quality center upon her departure.

Chief Data Officer at the U.S. Department of Health and Human Services (HHS) Mona Siddiqui also announced that she would be leaving her post at the administration to become a vice president at Humana. Siddiqui had held the position at HHS since 2017. During this time, she worked to streamline the department’s data operations and led its artificial intelligence (AI) strategy. Her replacement was not immediately announced.


E&C Press FDA on Complex Generics Approvals


Bipartisan leadership of the House Energy and Commerce Committee has written to Commissioner of Food and Drugs Stephen Hahn, M.D. requesting information on the agency’s process for the approval of complex generic drugs. “The length of time leading to the approval of some recently approved complex generics raises questions of whether additional actions may be necessary to encourage the development of these products,” the lawmakers state. They request a response from the Food and Drug Administration (FDA) by January 31. The letter was sent by Chairman Frank Pallone (D-N.J.), Ranking Member Greg Walden (R-Ore.), Health Subcommittee Chairwoman Anna G. Eshoo (D-Calif.), Ranking Member Michael Burgess, M.D. (R-Texas), Oversight and Investigations Subcommittee Chair Diana DeGette (D-Colo.), and Ranking Member Brett Guthrie (R-Ky.).


JAMA Examines Changes in FDA Drug Approvals


A new report from the Journal of the American Medical Association (JAMA) indicates that the FDA is increasingly approving new drugs with fewer clinical trials. The analysis found that the number of drugs approved based on two pivotal trials decreased from 81 percent in 1995-1997 to 53 percent in 2015-2017. The number of drug applications including at least one pivotal trial in comparison to another drug decreased from 44 percent to 29 percent. The report also finds that an increasing number of companies are testing their products against a placebo or using historical data for evaluation.


Court of Appeals Considers White House DTC Advertising Rule


The U.S. Court of Appeals for the District of Columbia Circuit appear unlikely to reverse a July district court ruling that the U.S. Department of Health and Human Services (HHS) does not have the authority to require pharmaceutical manufacturers to disclose list prices in direct-to-consumer (DTC) advertising. Members of the three-judge panel questioned whether the regulation would increase Medicare and Medicaid administrative efficiency as HHS has argued. They also expressed doubt that the proposal would actually help control drug spending and noted that it would still not allow for consumers to evaluate the relative costs of different drugs. Merck, Eli Lilly, Amgen, and the Association of National Advertisers are suing HHS, asserting that the policy would confuse patients and discourage them from accessing treatment.


EPA Revises EtO Regulation


The Environmental Protection Agency (EPA) has revised a regulatory notice that sought information about how companies could use lower levels of ethylene oxide (EtO) in the sterilization of medical devices following objections from the FDA. The FDA argued that the EPA only has authority over releases of the chemical into the air, not over how much of it is used in sterilization plants. The EPA is attempting to update its emission standards in light of findings that EtO is at least 30 times more carcinogenic than previously thought.


FDA Committees Recommend Against New Opioid Approvals


The Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management advisory committees voted unanimously against the approval of Nektar’s oxycodegol last week. Oxycodegol is an opioid intended for the management of chronic lower back pain in adults for whom other treatment options are inadequate. It is one of the first products to be reviewed since the FDA’s issuance of a draft guidance regarding the consideration of broader public health risks in the approval of opioid medications. Nektar argued that its drug was less likely to be abused than currently-approved opioid products, stating that oxycodegol is designed to cross the blood-brain barrier slowly to reduce the potential for abuse or misuse. The FDA, however, asserted that the adverse events observed as a result of oxycodegol indicate an abuse potential similar to oxycodone. Several committee members acknowledged that oxycodegol may offer increased safety potential, but that Nektar needs to provide better supporting data. Other advisory committee members appeared hesitant about the introduction of any new opioid drugs to the market.

The advisory committees later deadlocked on a decision over whether to approve a combination pain drug from Esteve Pharmaceuticals. The product combines the non-opioid pain reliever celecoxib with tramadol, an opioid with low abuse potential. The drug’s sponsor argued that the formulation could be an alternative to more potent products. Advisory committee members, however, raised concerns about its efficacy. The FDA is not obligated to follow the recommendations of its advisory committees, but often does.



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