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Benzinga Medically Necessary: ​​FDA behind on facility inspections This is an excerpt from the March 4, 2021 edition of Medically Necessary, a healthcare supply chain newsletter. Subscribe here. Good afternoon. Medically Necessary is a newsletter by Matt Blois on the healthcare supply chain – how we get drugs, devices and medical supplies to healthcare providers and patients. FDA Delays on Facility Inspections The Problem: The U.S. Food and Drug Administration has largely stopped conducting surveillance inspections – periodic assessments of manufacturing plants to ensure drug quality – during the pandemic of coronavirus. The FDA carried out just three oversight inspections of foreign facilities between March and October 2020, up from more than 600 during the same period a year earlier. National surveillance inspections have also fallen, according to a recent report from the Government Accountability Office. The agency performed approximately 1,000 international inspections per year from 2016 to 2019. Approximately 74% of active ingredient manufacturers and 54% of finished drug manufacturing facilities for the US market are located outside the country. (Credit: Government Accountability Office) Why it’s important: A recent report from a team at the Johns Hopkins University School of Public Health indicates that the postponement of FDA inspections has contributed to drug shortages l last year, including essential drugs for the treatment of COVID-19 patients. The delays have also slowed the approval process for new drugs. The FDA recently postponed or denied approval of six drugs because it couldn’t inspect manufacturing facilities, according to this landmark Politico story. A guidance document for drugmakers says the FDA would try to approve applications for manufacturing facilities by collecting information remotely, but if an inspection is needed, it may have to delay a decision. The past: The GAO has criticized FDA’s oversight of an “increasingly global pharmaceutical supply” for years, according to the GAO report. The GAO determined that the FDA was not performing enough foreign inspections in 1998 and 2008. The agency made recommendations and increased inspections. Inspections started declining again in 2016. FDA officials said it was because they didn’t have enough staff to keep pace, according to GAO. The pandemic: While the FDA halted many inspections, the agency argued in an annual report from its pharmaceutical quality office that it is still meeting its most important goals. The agency continued some pre-approval inspections – necessary before a facility starts producing a drug – by requesting documents or relying on inspections by European regulators. The FDA has used these methods for over 150 pre-approvals. In 2020, the FDA approved production applications for 942 generic drugs, down slightly from 2019. The FDA has also told drug producers that changes in the manufacturing of drugs used to treat patients with COVID-19 would receive priority treatment and some regulatory flexibility in order to avoid shortages. In the absence of in-person inspections, the FDA has looked for other ways to monitor the quality of drug manufacturing during the COVID-19 pandemic. However, the GAO called some of these measures inadequate. The agency has enabled European regulators to vouch for the quality of drug manufacturers around the world. Normally, the FDA only accepts inspections by these regulators of European facilities. It has stepped up the inspection and testing of products as they enter the United States, which has caught dozens of drug quality issues. The future: The current backlog of inspections could also burden the drug supply chain for years to come. The GAO report notes that the FDA has not been able to perform more than 1,000 of its inspections scheduled for fiscal year 2020. The FDA aims to inspect drug manufacturers at least once every five years. . The backlog means the agency may not meet this target, increasing the risk of poor quality drugs entering the supply chain. Each year, the agency draws up a list of facilities that must be inspected. The most-at-risk locations – those that have never been inspected or have not been inspected in five years – are given priority. The remaining resources go to other facilities. Previously, the FDA spent less than a third of its inspection resources on the riskiest facilities, keeping the agency one step ahead. By 2022, GAO estimates that the FDA will need to use the vast majority of its resources on high-risk facilities. (Credit: Government Accountability Office) Back on track: In October, the FDA resumed conducting international inspections. The FDA performed nine pre-approval inspections in China in late 2020 and early 2021, but did not perform any surveillance inspections. The agency began inspections in India in January and completed two by February 25. Catch-up: Like a student pulling a sleepless night after procrastinating all semester, the FDA is looking for creative ways to cram inspections after falling behind. The FDA plans to continue using the tools, such as reports from European regulators and document reviews, that have helped it carry out its work during the pandemic, but is also exploring creative options to speed things up. The agency is investigating whether it could use video conferencing tools to perform remote inspections. The Johns Hopkins University team recommended the creation of new partnerships, similar to agreements with European countries, which would allow regulatory authorities in countries with advanced pharmaceutical markets, such as Australia or Japan, to take the place of FDA inspections during pandemics or other emergencies. The Bureau of Pharmaceutical Quality’s annual report also says the agency is developing a new risk management strategy to prepare for future disruptions. We don’t know what this strategy looks like. Biden promises vaccine doses for all American adults by May, prioritizes teachers (Photo: Flickr / Gage Skidmore CC BY-SA 2.0) Supply increase: Biden administration promises to have enough doses of COVID-19 vaccine to inoculate every adult in America by May. However, vaccinating every adult will be a different challenge. “It is not enough to have the vaccine supply. We need vaccinators – people to put the vaccines in the arms of the people, the millions of arms of Americans,” President Joe Biden admitted at the meeting. a press conference on Tuesday. Biden highlighted efforts by the federal government to increase the number of vaccinators, such as enlisting retired doctors and nurses, deploying federal emergency management personnel and the National Guard to administer vaccines. Focus on schools: Biden also called on states to start vaccinating teachers so schools can reopen. Many states are already doing this. The White House has set a goal of vaccinating all teachers by the end of March. “Let’s treat in-person learning as the essential service that it is. And that means the essential workers who provide that service – educators, school staff, educators – get immunized immediately,” Biden said Tuesday. The federal government plans to allow teachers to get vaccinated at retail pharmacies to achieve this goal. The numbers: There are still 18 states that have not made teachers eligible for early vaccines, according to a Kaiser Family Foundation policy database. In the 2017-18 school year, there were approximately 4 million teachers in the United States, according to the National Center for Education Statistics. The United States recently provided about 1.8 million doses of COVD-19 vaccine per day. Some days are well over 2 million doses, according to the Centers for Disease Control and Prevention. The U.S. government sends about 2.4 million doses to retail pharmacies each week, White House COVID-19 Advisor Andy Slavitt reported on Twitter. Reading List: The Best Stories In The Healthcare Supply Chain A Needle-Free Covid-19 Vaccine? These companies are on the right track – Wall Street Journal Freight pilots use Covid-19 vaccines around the world – and in turn ask to be vaccinated – STAT health care provider Amazon Care has quietly filed claims Documents to Operate in 17 Other States – STAT Merck’s COVID Manufacturing Agreement with U.S. Government Goes Way Beyond J&J Vaccine – The Pink Leaf Thanks for reading. Please email [email protected] if you have any questions, praise or grievances. If this email has been forwarded to you, sign up here. Matt Blois See more from BenzingaClick here for 2021 BenzingaAir Cargo options trading: The Good, The Bad And The Ugly Benzinga does not provide investment advice. All rights reserved.



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