BakerHostetler FDA and Pharmacy Weekly Digest

Alerts / October 23, 2018

Last week Health and Human Services (HHS) released its Statement of Regulatory Priorities for Fiscal Year 2019. Several of the FY19 priorities include: (1) combatting the opioid crisis; (2) strengthening individual health insurance program; (3) tackling the high cost of prescription drugs; (4) eliminating obsolete regulations; (5) providing necessary regulatory clarity to industry stakeholders; and, (6) keeping pace with 21st century science.

Food/Dietary Supplements

FDA Amends Regulations to Remove Certain Flavoring Agents – The Food and Drug Administration (FDA) recently released a statement that it would amend its food additive regulations to remove seven synthetic flavoring substances and flavor enhancements. Six of the agents are being removed because they were shown to cause cancer in laboratory animals. The seventh flavor is being removed because it is no longer utilized by the industry. The flavors include synthetically derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, pyridine and styrene.


HHS Announces Plan to Address Drug Pricing in TV Ads – HHS Secretary Azar announced a plan to “require American drug companies, for the first time ever, to include in their TV advertising the list price of any drug paid for by Medicare or Medicaid.” This announcement comes shortly after the president signed into law the Lowest Price Act and the Patient Right to Know Drug Prices Act. The industry quickly responded through PhRMA to announce “their commitment to providing more transparency about medicine costs.”

FDA Announces Drug Competition Action Plan – The plan focuses on three specific areas to increase generic competition, enhance patients' access to medications and “improve the economics of developing generic medicines.” A key aspect of this plan is to create global development standards for generic drug products through the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

FDA Publishes Guidance on Direct-to-Consumer (DTC) Advertising – The draft guidance document provides recommendations on how organizations can make their efficacy and risk information in DTC advertising more consumer-friendly. Comments on the draft are due on Dec. 17, 2018.

FDA Alerts Healthcare Professionals and Patients of Drug Shortage Extended Use Dates and Updates Shortage List – FDA determined that certain sterile water for injection may be used beyond the manufacturer’s labeled expiration date because of “intermittent supply interruption.” FDA also added two drugs to the drug shortage list: Diltiazem Hydrochloride ER (Twice-a-Day) Capsules (new –currently in shortage) and Ondansetron Hydrochloride Injection (updated – currently in shortage).

FDA Publishes Guidance About Targeted Therapies – FDA issued a final guidance document designed to demonstrate the “FDA’s current recommendations on how to group patients with different molecular alterations for eligibility in clinical trials” and to provide “general approaches to evaluating the benefits and risks of targeted therapies within a clinically defined disease where some molecular alterations may occur at low frequencies.”

Price Fixing Litigation – A federal court found that more than 20 generic drug manufacturers can face multidistrict litigation related to price-fixing.

Medical Devices

FDA Issues 510(k) Guidance on Benefit-Risk Factors – This final guidance document is intended to assist submitters with demonstrating substantial equivalence when the benefit-risk profile of a new device is not the same as that of predicate device. This guidance does not add additional regulatory requirements on submitted, but is intended to provide clarity about the substantial equivalence portion of the submission process.


Cosmetics Reform Bill Introduced – Representative Schakowsky sponsored HR 6903, the “Safe Cosmetics and Personal Care Product Act of 2018”. The bill proposes to update registration and labeling requirements for cosmetics and to address safety standards and ingredient safety.


HHS/FDA Announce Long-Term Actions for Tobacco Products – These actions include tobacco product standard for nicotine levels, information related to premium cigars, and administrative detention of tobacco products.

FDA Seeks Information From E-cigarette Companies – The FDA issued information requests to 21 e-cigarette companies. The letters focus on the company’s marketing practices. FDA indicated that the letters are “not intended to communicate that FDA is considering enforcement action.”

Recently Posted Warning Letters

FDA recently posted warning letters addressed to an e-cig company related to the sale of e-liquids, to an animal food organization related to the sale of products containing animal drugs, to a commercial feed mill related to foods for livestock, and to a drug manufacturer for violations of good manufacturing practices.


California PBM Bill Enacted – California recently enacted AB-315, relating to pharmacy benefit management. The bill requires “a pharmacy to inform a customer at the point of sale for a covered prescription drug whether the retail price is lower than the applicable cost-sharing amount for the prescription drug, unless the pharmacy automatically charges the customer the lower price.”

For more information, visit team, or contact the BakerHostetler FDA Team.

Authorship credit: Lee H. Rosebush, Lance L. Shea and Lindsay P. Holmes

Baker & Hostetler LLP publications are intended to inform our clients and other friends of the firm about current legal developments of general interest. They should not be construed as legal advice, and readers should not act upon the information contained in these publications without professional counsel. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you written information about our qualifications and experience.