FDA Released a Supplemental Draft Guidance for the Intentional Adulteration Rule Under the Food Safety Modernization Act – The Food & Drug Administration (FDA) announced the availability of a supplemental draft guidance, Mitigation Strategies to Protect Food Against Intentional Adulteration. The supplement is intended to help food facilities comply with, develop and implement some of the components of a food defense plan under 21 C.F.R. part 121.
FDA Issued Final Rule to Define ‘Biological Product’ – This final rule amends FDA’s regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 and the Further Consolidated Appropriations Act, 2020. The rule also defines the term “protein” to mean “any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size.”
FDA Announced Two FAQ Documents on Regulatory Changes for Biological Products – The documents provide information for patients and health care providers regarding the upcoming transition of some products approved under the Federal Food, Drug, and Cosmetic Act the Public Health Service Act as required by the Biologics Price Competition and Innovation Act of 2009. The transition date is March 23. The Preliminary List of products that will be transitioned was last updated on December 31, 2019.
FDA Released Data Set of Drug Approvals Since 1985 – The data set is intended to provide researchers with more information on new molecular entities approved under a New Drug Application and new biological products approved under a Biologics License Application. Information fields include but not limited to proprietary name, active ingredient, applicant, application number, dosage form, route of administration, approval year, approved uses and priority status.
FDA Announced the Release of a Searchable Purple Book Database – Like the Orange Book database lists for drugs, the Purple Book Database will list licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations. FDA plans to publish a Federal Register notice and open a docket to gather public comment on the database to inform the next phases of development.
FDA Will Hold a Public Workshop on Using Patient Preference Information in Medical Device Regulatory Decisions – The public meeting, Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond, will be held on March 31. Topics will include the value of including patient preference information (PPI) in different settings, case studies highlighting the use of PPI and methodologies for collecting PPI. The FDA will also hold a pre-meeting webinar on March 4.
FDA Released Table of Pharmacogenetic Associations – The table lists pharmacogenetic associations that FDA has evaluated and believes “there is sufficient scientific evidence to suggest that subgroups of patients with certain genetic variants, or genetic variant-inferred phenotypes, are likely to have altered drug metabolism, and in certain cases, differential therapeutic effects, including differences in risks of adverse events.” Pharmacogenetic tests may be used to aid in determining a therapeutic strategy, determining an appropriate dosage, or assessing the likelihood of benefit or toxicity when health care providers prescribe drugs.
House to Soon Vote on Bill to Ban Flavored Tobacco Products – The Reversing the Youth Tobacco Epidemic Act would ban the flavoring of tobacco products and electronic nicotine delivery systems. The bill also prohibits the online sale of tobacco products. If the bill is passed, the FDA could approve flavored electronic nicotine delivery systems as a tobacco cessation product or for another therapeutic purpose.
Pharmacy Benefit Manager Released a Drug Trend Report for 2019 – The report highlighted increases in the share of costs paid by patients, the share of spend for specialty drugs and the price of brand-name drugs.
Kentucky House of Representatives Passed Bill to Cap Insulin Cost Sharing – Kentucky House Bill 12 is now in the Kentucky Senate. The bill caps out-of-pocket costs for covered prescription insulin at $100 for a 30-day supply, regardless of the amount or type of insulin needed to meet the covered person’s insulin needs. The bill also does not allow private third-party payers to reduce or eliminate coverage due to a patient’s diabetic status.
New Mexico Bill Awaits Governor Signature – The New Mexico House and Senate passed House Bill 42 to provide Pharmaceutical Service Reimbursement Parity. If signed by the governor, the bill would allow pharmacists with prescriptive authority to be reimbursed for clinical services.
Coronavirus Will Alter FDA’s Drug Surveillance Inspections in China – FDA released a coronavirus update. In response to coronavirus, “the FDA will utilize … [its] authority to request records from firms ‘in advance or in lieu of’ drug surveillance inspections in China.” When inspections in China resume, FDA will use the paper records to prioritize inspections using a risk-based approach.
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