Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health policy news.
I. Regulations, Notices, & Guidance
- On February 25, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Assessing the Effects of Food on Drugs in INDs and NDAs - - Clinical Pharmacology Considerations. The guidance provides recommendations to sponsor planning to conduct food-effect trials for orally administered products as part of investigational new drug applications (INDs), new drug applications (NDAs), and supplements to these applications. This guidance, when final, revises and replaces part of the 2002 FDA guidance for industry entitled, Food-Effect Bioavailability and Fed Bioequivalence Studies.
- On February 26, 2019, the FDA issued guidance entitled, Quality Considerations for Continuous Manufacturing. This draft guidance provides information regarding FDA's current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER). The draft guidance describes several key quality considerations and provides recommendations for how applicants should address these considerations in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs, for small molecule, solid oral drug products that are produced via a continuous manufacturing process. FDA supports the development and implementation of continuous manufacturing for drug substances and all finished dosage forms where appropriate, including those submitted in NDAs, ANDAs, drug master files, biologics license applications (BLAs), and non-application over the counter products. Scientific principles described in this draft guidance may also be applicable to continuous manufacturing technologies used for these drugs. However, this draft guidance is not intended to provide recommendations specific to continuous manufacturing technologies used for biological products under a BLA.
- On February 27, 2019, the Department of Health and Human Services (HHS) issued a final rule entitled, Compliance with Statutory Program Integrity requirements. HHS issues this final rule to revise the regulations that govern the Title X family planning program (authorized by Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where abortion is a method of family planning and related statutory requirements. Accordingly, OPA amends the Title X regulations to clarify grantee responsibilities under Title X, to remove the requirement for nondirective abortion counseling and referral, to prohibit referral for abortion, and to clarify compliance obligations with state and local laws. In addition, Title X regulations are amended to clarify access to family planning services where an employer exercises a religious or moral objection. Finally, Title X regulations are amended to require physical and financial separation to ensure clarity regarding the purpose of Title X and compliance with statutory program integrity provisions, and to encourage family participation in family planning decisions, as required by Federal law.
- March 11, 2019: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). The PTAC meeting will include deliberation and voting on proposals for physician-focused payment models submitted by individuals and stakeholder entities.
- March 13-15, 2019: HHS announced a public meeting for all new public requests for revisions to the Healthcare Common Procedure Coding System coding and payment determinations.
- April 2-3, 2019: The Health Resources and Service Administration (HRSA) announced a meeting of the National Advisory Council on the National Health Service Corps (NHSC). No agenda has been posted but the Council is expected to make recommendations on the NHSC.
- April 10, 2019: The FDA announced a public meeting entitled, Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards. The purpose of the meeting is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission systems’ past performance, future targets, emerging industry needs and technology initiatives.
- April 29, 2019: The FDA announced a public meeting entitled, Perspectives on the Impact of Rare Diseases: Bridging the Commonalities. The meeting is intended to obtain patients’ and caregivers’ perspectives on impacts of rare diseases on daily life and to asses commonalities that may help the FDA and medical product developers further understand and advance the development of treatments for rare diseases.
II. Congressional Legislation & Committee Action
U.S. Senate- On February 26, 2019, the Senate Finance Committee held a hearing entitled, Drug Pricing in America: A Prescription for Change, Part II. Witnesses included: Richard Gonzalez, Chairman and Chief Executive Officer (CEO), AbbVie Inc.; Pascal Soriot, Executive Director and CEO, AstraZeneca; Giovanni Caforio, M.D., Chairman of the Board and CEO, Bristol-Myers Squibb Co.; Jennifer Taubert, Executive Vice President, Janssen Pharmaceuticals, Johnson & Johnson; Kenneth Frazier, Chairman and CEO, Merck & Co., Inc.; Albert Bourla, Ph.D., CEO, Pfizer; and Oliver Brandicourt, M.D., CEO, Sanofi.
- On February 27, 2019, the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing entitled, Food and Drug Administration – Status of Operations. FDA Commissioner Scott Gottlieb testified.
III. Reports, Studies, & Analyses
- On February 25, 2019, the Journal of Managed Care & Specialty Pharmacy issued a report entitled, Effect of Evergreened Reformulations on Medicaid Expenditures and Patient Access from 2008 to 2016. The study examined 73 drug active ingredients that were subject to evergreened reformulations and these reformulations increased Medicaid expenditures from 2008-2016 by $9.3 billion.
IV. Other Health Policy News
- On February 28, 2019, the HHS Office of Inspector General (OIG) reviewed the Centers for Disease Control and Prevention’s (CDC) audit compliance rate. The OIG found that the CDC generally resolves audit issues, although it is not done quickly. The OIG conducted this review to ensure the CDC had resolved issued raised from a number of audits conducted in 2015 and 2016. The report is available here.