United States: FDA And Pharmacy Weekly Digest - April 1

Food/Dietary Supplements

Public Meeting on Intentional Adulteration Rule – On April 17, 2019, the U.S. Food and Drug Administration (FDA) will hold a public meeting on the draft guidance it issued related to the Intentional Adulteration rule. Registration is open until April 10, 2019.

FDA Issues Revised Q&A on Veterinary Feed – The FDA published a revised draft guidance, intended to act as a small entity compliance guide, titled "Veterinary Feed Directive Regulation Questions and Answers (Revised)." This guidance is intended to help veterinarians, feed distributors and animal owners comply with the veterinary feed directive regulations.


FDA Encourages Expanded Access – The FDA announced its hope that sponsors would offer expanded access to investigational drug products in certain circumstances, including situations after a clinical trial has ended.

FDA Releases Guidance on Biological Product Development Standards – The FDA issued a guidance titled "Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research." The guidance is intended to provide the "recommendations of the Center for Biologics Evaluation and Research (CBER) on the use of standards in product development and control as well as the use of such standards in CBER's managed review process."

FDA Issues Guidance on Pediatric Information Labeling – The FDA published a guidance titled "Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling." The purpose of the guidance is to "assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products."

Medical Devices

FDA Aims to Modernize Mammography Services – The FDA announced that it plans to amend "key regulations that would help improve the quality of mammography services for millions of Americans." Changes would include broadening the information that mammography providers would be required to give patients and providers.

FDA Takes Steps to Address Device Shortage and Sterilization Concerns – Due to the closure of one contract sterilization organization and the planned closing of another, the FDA is working to address potential shortages and the availability of safe and effective medical device sterilization. With respect to shortages, the FDA is "working directly with manufacturers, as needed, to help them transition to another sterilization site or sterilization method."

FDA Tackles Blood Pathogen Reduction Technologies – The FDA announced the need for more advanced blood pathogen reduction technologies. The FDA stated, "Current pathogen reduction technologies have certain limitations. For example, they don't inactivate some viruses like parvovirus, and they don't address prions, which are protein based infectious agents." Due to the limitations of current technology, the FDA "is working with a variety of different partners to pursue multiple avenues of research to advance pathogen reduction technology."

FDA Releases Device Establishment Inspection Guidance – The FDA issued a draft guidance titled "Review and Update of Device Establishment Inspection Processes and Standards." The guidance outlines how the FDA "will implement uniform processes and standards that are applicable to inspections (other than for-cause) of foreign and domestic medical device establishments."

FDA Publishes Bacillus spp. Detection Device Guidance – The FDA released a guidance titled "Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection." The purpose of the guidance is to identify "measures that FDA believes are necessary to mitigate the risks to health associated with devices of this type and provide a reasonable assurance of safety and effectiveness."


FDA Announces New Actions to Advance Tobacco Regulation – The FDA reiterated its commitment to its comprehensive plan on tobacco, which it released in 2017. In addition to releasing a proposed rule, the FDA plans to make more resources available via its website about enhancements to the process for tobacco product applications.

FDA Issues Proposed Rule on Substantial Equivalence Reports – The FDA released a proposed rule "to establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product (SE Reports)." The proposed rule will outline the information that must be included in the SE Reports.


Commissioner Gottlieb Announces Opioid Crisis as FY 2020 Priority – In his remarks before the U.S. Senate Subcommittee on Appropriations, FDA Commissioner Scott Gottlieb listed the opioid crisis as one of his highest priorities. He stated, "This is the biggest public health crisis facing the agency, and remains one of the biggest crises facing our nation. The contours of this crisis are changing from a crisis that was formed largely in the medical setting, often through prescription drugs that were prescribed lawfully but far too loosely; to a crisis that increasingly involves the use of illicit drugs like super-potent fentanyls. But the fact remains that we still need to take more steps to rationalize prescribing, and too many prescriptions are still being written, and they're being prescribed for durations of use that are too long for the underlying indication."

FDA Announces Plan to Address Fentanyl Risks – The FDA announced steps to enhance the REMS program for transmucosal immediate-release fentanyl, including "[r]equiring inpatient pharmacies to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized."

Citizens Petition Related to Compounding Filed – A number of organizations filed a Citizens Petition "ask[ing] FDA to reconsider its Final Rule published as FDA docket FDA-2016-N-3464-0029, List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act, published on February 19, 2019."

PBM Bill Passes in Montana – The Montana legislature passed SB 83, which outlines a number of prohibited practices by pharmacy benefit managers (PBMs). The bill includes a probation on certain fees a PBM may charge a pharmacy.

House Bill Introduced to Address Compounding – Rep. H. Morgan Griffith introduced H.R.1959, which would amend the Federal Food, Drug, and Cosmetic Act related to compounding, including office use.

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