United States: BakerHostetler FDA And Pharmacy Weekly Digest - November 5, 2018

Food/Dietary Supplements

FDA Issues Added Sugar Guidance – The FDA announced the availability of a guidance document that answers questions about the new food labeling requirements. A large portion of the guidance is focused on “added sugar” labeling, including the definition of added sugars, calculating the amount of added sugars and how certain types of ingredients impact the added sugars declaration.

FDA Issues a Request for Information on Sesame – The FDA is seeking information on the prevalence and severity of sesame allergies in the U.S. This information will be used to determine whether regulatory action should be taken related to disclosure of sesame as an allergen in products. The comment period closes on Dec. 31, 2018.


President Trump Aims to Lower Drug Prices – President Donald Trump announced that he would seek to curb drug prices by “allow[ing] Medicare to determine the price it pays for certain drugs based on the cheaper prices paid by other nations.” He continued by saying that “we’re paying a price based on the price that other nations are paying. That’s what we’re going to pay. No longer seven times more. No longer 10 times, 11 times, even 12 times more – I’ve seen examples of paying the same price.” The CEO of PhRMA criticized Trump’s announcement, saying, “The administration is imposing foreign price controls from countries with socialized health care systems that deny their citizens access and discourage innovation. These proposals are to the detriment of American patients. The United States has a competitive marketplace that controls costs and provides patients with access to innovative medicines far earlier than in countries with price controls, and it’s why we lead the world in drug discovery and development. Americans have access to cancer medicines on average about two years earlier than in developed countries like the United Kingdom, Germany and France.”

Drug Approval Announcement –  The FDA recently announced the approval of a drug “for the treatment of cataplexy and excessive daytime sleepiness (EDS) in pediatric patients (7 to 17 years old) with narcolepsy.”

Medical Devices

FDA Authorizes First DTC Genetic Test for Genetic Variants – The FDA announced that it will permit 3andMe Personal Genome Service Pharmacogenetic Reports to be marketed direct-to-consumer (DTC). The test detects “genetic variants that may be associated with a patient’s ability to metabolize some medications to help inform discussions with a health care provider. The FDA is authorizing the test to detect 33 variants for multiple genes.”

FDA Issues Public Advisory Committee Meeting – The FDA announced a Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting that will be held Dec. 4-5, 2018.

FDA Removes Two Proposed Device Rules – The FDA announced the removal of two proposed rules because they “are not currently considered viable candidates for final action.” The FDA indicated that the proposed rules need to be reconsidered in light of the comments it received and new information available since the publication of the rules. The rules being removed are (1) Laser Products; Proposed Amendment to Performance Standard and (2) Electronic Submission of Labeling for Certain Home-Use Medical Devices.

FDA Warns Patients Against Using Genetic Tests for Certain Purposes – The FDA expressed concerns about unsubstantiated claims being made by some genetic tests and issued an advisory “alerting patients and health care providers that claims for many genetic tests to predict a patient’s response to specific medications have not been reviewed by the FDA, and may not have the scientific or clinical evidence to support this use for most medications. Changing drug treatment based on the results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for the patient.”


FDA Removes a Color Additive – The FDA announced through a final rule that the color additive regulations are being amended “to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp because new data available since lead acetate was permanently listed demonstrate that there is no longer a reasonable certainty of no harm from the approved use of this color additive.” This rule allows a 30-day period for objections to be raised, and the rule will become effective 30 days after the objection period ends if there are no objections.


FDA Issues Notice on MRTPA – The FDA reopened for public comment a docket related to a modified risk tobacco product application (MRTPA) for a specific tobacco product. The original notice was opened in 2014 and reopened in 2015. The comment period is being opened again to seek specific comment on the recent MRTPA amendment submitted by a tobacco company.


HHS Ends Delay of 340B Rule – HHS announced through a notice of proposed rulemaking that it would “cease any further delay of the rule establishing the calculation of the 340B ceiling price and application of civil monetary penalties.” The rule’s effective date will be changed to Jan. 1, 2019.

Akron Doctor Banned From Practicing Medicine Permanently – The DOJ announced that a federal judge approved a settlement permanently prohibiting an Ohio doctor from prescribing opioids or practicing medicine. The action was taken after allegations that the doctor illegally prescribed and sold opioids.

2020 Part D Proposed Rule Released – CMS issued a proposed rule aimed at “promoting flexibility and innovation so that MA and Part D sponsors are empowered with the tools to improve quality of care and provide more plan choices for MA and Part D enrollees.” There was speculation that this rule would address drug costs and DIR fees, but that remains to be seen. The rule does address expanded access to telehealth services. HHS-CMS also submitted a proposed rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Costs (CMS-4180-P)” to the Office of Management and Budget (OMB), which is indicated to be “Economically Significant.”

NRC Issues Request for Comment – The Nuclear Regulatory Commission (NRC) is seeking comment on training and experience requirements related to certain radiopharmaceuticals. Specially, “the NRC would like input on whether it should establish tailored T&E requirements for different categories of radiopharmaceuticals for which a written directive is required in accordance with its regulations.” Comments will be used to determine whether regulatory changes are required in this space.

Birth Control Proposed Rule Set to Finalize This Month – The proposed rule impacting pharmacists and pharmacies set to “revise regulations previously promulgated to ensure that persons or entities are not subjected to certain practices or policies that violate conscience, coerce, or discriminate, in violation of such Federal laws,” will likely finalize this month.

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