In a marathon session Sept. 21 in which the U.S. House suspended the rules to vote on more than 50 bills, it passed H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act, along with nine other health-related bills.
H.R. 4866 would amend the 21st Century Cures Act to direct the FDA to designate national centers of excellence (NCEs) that would work with the agency and the biopharma industry to craft a national framework for continuous manufacturing. The bill also calls for support for additional R&D of the technology, workforce development, standardization and collaboration with drug manufacturers to help them adopt continuous manufacturing. The bill authorizes $80 million to be appropriated for the NCEs each year from fiscal 2021 through 2025.
One of the other bills passed by voice vote is intended to strengthen the Strategic National Stockpile (SNS), “which is so critical as we continue to combat the COVID-19 pandemic and prepare for future public health emergencies,” Reps. Frank Pallone (D-N.J.) and Anna Eshoo (D-Calif.) said in a joint statement following the vote. Pallone chairs the House Energy and Commerce Committee, which deals with health-related issues, and Eshoo chairs that committee’s Health Subcommittee.
H.R. 7574, the Strengthening America’s Strategic National Stockpile Act, would improve the financial security of the stockpile by authorizing it to sell products within six months of expiration to other federal departments or agencies. In addition, the bill requires the secretary of Health and Human Services to ensure that the contents of the SNS are in good working order.
“This pandemic has shown us how important it is to strengthen our domestic pharmaceutical manufacturing and Strategic National Stockpile, and the bills advanced will help achieve these goals,” Reps. Greg Walden (R-Ore.) and Michael Burgess (R-Texas) said in a separate statement. Walden and Burgess are the Republican leaders, respectively, of the Energy and Commerce Committee and the Health Subcommittee.
A third bill, H.R. 5663, the Safeguarding Therapeutics Act, would give the FDA the authority to destroy certain imported medical devices, such as diagnostic tests or surgical masks, that are thought to be adulterated, misbranded or unapproved and that may pose a threat to public health. The agency already has the authority to destroy imported drugs for those reasons.
The other health-related bills that were passed “address shortcomings and make strategic improvements throughout our health care system. They address the maternal mortality crisis, study and prevent sudden infant and child death, ensure Medicaid beneficiaries have access to nonemergency medical transportation and support programs to prevent self-harm and suicide,” Pallone and Eshoo said.
While the legislation, most of which was bipartisan, will be forwarded to the Senate, there’s no guarantee the Senate will consider the bills before the election or in the lame duck session that follows. Legislation that isn’t passed in this Congress will have to start all over in the 117th Congress, which will be seated in January.
New TGA service to ease the burden of biowaivers
Australia’s Therapeutic Goods Administration (TGA) launched a new initiative Sept. 22 that will enable applicants to request scientific advice on specific data before they apply to register a medicine.
Initially, the Access to the Early Scientific Advice service will provide advice on “biowaiver” justifications. An internationally recognized concept, a biowaiver allows applicants to submit reduced data to show that one drug is bioequivalent to another.
While the TGA website provides a range of information to help companies understand what data are needed to show bioequivalence, “the highly technical nature of these requirements means it may not always be clear whether specific data would support a biowaiver justification,” the TGA said. “Applicants may invest considerable time and resources into developing data that is not needed, or may leave out data that is needed. In either case, this may delay access to new medicines for consumers.”
The Early Scientific Advice service, which was made possible by a legislative change earlier this year, is expected to help applicants reduce their drug development costs.
As part of the launch of the new service, the TGA issued a guidance on how to request early scientific advice on data to support biowaiver justifications.
FDA formalizes outside experts program
The FDA said that an informal network of experts is now a formal program that will be known as the Network of Experts Program (NEP), a vetted network of partner organizations and member scientists who are available to assist the FDA staff with technical expertise.
The informal program began in 2012 at the FDA’s Center for Devices and Radiological Health with three partner organizations and grew organically from there, with the FDA’s Center for Drug Evaluation and Research joining in 2017.
The program now boasts more than 100 professional organizations and includes a network of digital health experts, a large number of medical societies and other organizations, such as the American Chemical Society and the Association of Public Health Laboratories. Member organizations must be 501(c)(3) nonprofits.
FDA unveils Digital Health Center of Excellence
The U.S. FDA announced the opening of its Digital Health Center of Excellence, a pool of digital health resources across the agency that will focus largely on “innovative regulatory approaches” for regulation of digital health products.
Other objectives of the center will be to share knowledge to foster best practices and to connect with other organizations to accelerate digital health advancements.
The three-phase program for the center will start with raising awareness and engaging with stakeholders throughout fall 2020. The second phase, which will run through the winter of 2020-2021, will be directed toward building partnerships, including the assembly of digital health advisory committees. The final phase will include a build-up of sustainable capacity.
The agency will hold two listening sessions on the new center Oct. 19 and Nov. 12, 2020.
FDA updates clinical trial guidance
The FDA added a new question-and-answer to the appendix of its guidance, “Conduct of clinical trials of medical products during COVID-19 public health emergency.”
The new entry centers on a trial investigator’s responsibility to review all investigational new drug application safety reports, including ones that will not result in a change to the investigator brochure, informed consent or protocol, the agency said.