Issue link: https://www.e-digitaleditions.com/i/1222740
Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 5 facilities in China, India, South Korea, Germany, Australia, Trinidad and Tobago, and Mexico. The regulatory issues cited during these inspec- tions include failure to inspect or test components or materials from suppliers, inadequate batch records, lack of supplier oversight, inadequate quality control units, inadequate control of computer systems, lack of laboratory controls, lack of written procedures, failure to validate the reliability of a supplier's ma- terials, failure to conduct release testing, and failure to use appropriately designed, sized, located, and maintained equipment. These citations are typical of past violations. Now, the global pandemic brought on the COVID-19 coronavirus adds further uncertainty to the qual- ity of drugs for patients in the US. A new normal for quality? The rapid spread of COVID-19 has stressed FDA's resources to protect patients in the US while moni- toring a global supply chain. The agency issued emergency use authorizations to accelerate diag- nostic testing and issued warning letters to seven companies for selling fraudulent COVID-19 prod- ucts. Its oversight role was disrupted as travel bans lead to the postponement of foreign inspections. FDA expressed confidence in the agency's ability to maintain oversight of foreign manufacturers using other tools and methods (3). While supermarkets and drug store shelves were emptied of cold medicines, FDA also said it was monitoring the supply chain. The agency has iden- tified drugs that may be susceptible to shortages due to supply chain disruptions to ingredients and finished drug products and was committed to assist manufacturers with potential shortages. The positive progress made by the bio/pharma in- dustry—including innovation and rapid approval of therapies—will be tested in the coming months as the bio/pharma industry and regulators adjust to a "new normal" of supply chain disruptions, travel restrictions, economic upheaval, and health threats to the workforce. References 1. FDA, "Office of Pharmaceutical Quality, 2019 Annual Report, One Quality Voice," February 2020. 2. FDA, "Recalls, Market Withdrawals, & Safety Alerts," www.fda. gov, accessed March 16, 2020. 3. FDA, "Coronavirus Disease 2019 (COVID-19)," www.fda.gov, ac- cessed March 16, 2020. PT The regulatory approval pathway for certain protein-based drug products— including insulin and insulin analogs, human growth hormone, pancreatic enzymes, and reproductive hormone—will transition from FDA approval as a "biological product" under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act) effective March 23, 2020 (1). As specified in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), proposed products submitting a marketing application after March 23, 2020—that previously could have been submitted under section 505 of the FD&C Act—must submit a marketing application under section 351 of the PHS Act as a 351(a) "stand-alone" BLA or a 351(k) BLA for a proposed biosimilar product or a proposed interchangeable product. In addition, nearly 100 drugs previously approved under a new drug application (NDA) as a "biologic product" will transition to biologic license application status on March 23, 2020. This change to the approval pathway for certain biologic drugs can pave the way for marketing applications for products that are biosimilar to the approved originator drug, FDA notes. The Further Consolidated Appropriations Act, 2020, enacted on December 20, 2019, further amended the definition of a "biological product" in the PHS Act include chemically synthesized products that fall within the interpretation of "protein" to be within the definition of "biological product" and subject to the statutory transition. The legislative change does not affect polymers composed of 40 or fewer amino acids. FDA has published a list of affected drugs, a final rule on the definition of the term "biological product," as well as answers to common questions about the implementation. Reference 1. FDA, "'Deemed to be a License' Provision of the BPCI Act," www.fda.gov. From NDA to BLA?