Benzinga
Medically necessary: FDA falls behind in facility inspections
This is an excerpt from the March 4, 2021 edition of Medically Necessary, a health supply chain newsletter. Register here. Good afternoon. Medically Necessary is a Matt Blois newsletter on the health supply chain – how we provide medicines, devices and medical supplies to healthcare professionals and patients. FDA is long overdue on facility inspections The problem: The US Food and Drug Administration has stopped conducting surveillance inspections – periodic factory reviews to ensure the quality of the drug – during the coronavirus pandemic. The FDA conducted only three surveillance inspections of the foriegn facilities between March and October 2020, compared with more than 600 during the same period last year. Home surveillance inspections have also plummeted, according to a recent report by the Government Accountability Office. The agency conducted about 1,000 international inspections per year from 2016 to 2019. About 74% of active ingredient manufacturers and 54% of finished drug facilities for the US market are located outside the country. (Credit: Government Accountability Office) Why it matters: A recent report by a team from the Johns Hopkins University School of Public Health says that postponed inspections by the FDA contributed to a shortage of drugs in the past year, including essential drugs for treatment of patients with COVID-19. The delays also slowed the approval process for new drugs. The FDA recently postponed or denied approval for six drugs because it could not inspect the manufacturing facilities, according to this politico’s must-read story. A guidance document for drug manufacturers notes that the FDA would attempt to approve orders for manufacturing facilities by collecting information remotely, but if an inspection is necessary, it may be necessary to delay a decision. The past: GAO has criticized the FDA’s oversight of “an increasingly global pharmaceutical supply” for years, according to the GAO report. GAO determined that the FDA was not conducting sufficient foriegn inspections in 1998 and 2008. The agency made some recommendations and increased inspections. Inspections began to drop again in 2016. FDA officials said that this was because they did not have enough staff to follow up, according to GAO. The pandemic: Although the FDA has stopped many inspections, the agency argued in an annual report from its Office of Pharmaceutical Quality that it still achieved its most important objectives. The agency continued some pre-approval inspections – necessary before a facility starts producing a drug – by requesting documentation or relying on inspections from European regulators. The FDA has used these methods for more than 150 pre-approvals. In 2020, the FDA approved orders for the production of 942 generic drugs, just slightly below 2019. The FDA also told drug producers that changes in the manufacture of drugs used to treat patients with COVID-19 would receive priority treatment and some regulatory flexibility in order to prevent shortages. In the absence of personal inspections, the FDA looked for other ways to monitor the quality of drug manufacturing during the COVID-19 pandemic. However, GAO considered some of these measures to be inadequate. The agency has allowed European regulators to guarantee the quality of drug manufacturers around the world. Normally, the FDA only accepts inspections from these European facility regulators. He stepped up product inspection and testing as soon as they entered the United States, which detected dozens of drug quality problems. The future: the current accumulation of inspections may also disrupt the drug supply chain for years to come. The GAO report notes that the FDA has not been able to complete more than 1,000 of its planned inspections for fiscal 2020. The FDA aims to inspect drug manufacturers at least once every five years. Accumulation means that the agency may not meet this target, increasing the risk that low-quality drugs will enter the supply chain. Each year, the agency creates a list of facilities that need inspection. The highest-risk sites – those that have never been inspected or have not been inspected in five years – have priority. The remaining resources go to other facilities. Previously, the FDA spent less than a third of its inspection resources at the most risky facilities, allowing the agency to stay ahead of the curve. In 2022, GAO estimates that the FDA will need to use the vast majority of its resources in high-risk facilities. (Credit: Government Accountability Office) Back on horseback: In October, the FDA started conducting some international inspections once again. The FDA conducted nine pre-approval inspections in China during late 2020 and early 2021, but has not completed any surveillance inspections. The agency began inspections in India in January, completing two on February 25. Catching Up: As a college student who takes an entire night out after procrastinating the entire semester, the FDA is looking for creative ways to stick with inspections after being left behind. The FDA plans to continue using tools, such as reports from European regulators and document reviews, that helped it do its job during the pandemic, but is also exploring creative options to speed things up. The agency is researching whether it could use video conferencing tools to conduct inspections remotely. The Johns Hopkins University team recommended creating new partnerships, similar to agreements with European countries, that would allow inspections by regulators from countries with advanced pharmaceutical markets, such as Australia or Japan, to replace FDA inspections during pandemics or other emergencies. The Office of Pharmaceutical Quality annual report also says that the agency is developing a new risk management strategy to prepare for future disruptions. It is not clear what this strategy looks like. Biden promises vaccine doses for all US adults by May, prioritizes teachers (Photo: Flickr / Gage Skidmore CC BY-SA 2.0) Increased supply: Biden’s administration is promising to have enough doses of COVID-19 vaccines to inoculate everyone adults in America until May. However, vaccinating each adult will be a different challenge. “It is not enough to have the vaccine stock. We need vaccinators – people to put vaccines in people’s arms, millions of Americans in their arms,” President Joe Biden acknowledged during a news conference on Tuesday. Biden highlighted the federal government’s efforts to increase the number of vaccinators, such as recruiting retired doctors and nurses, sending Federal Emergency Management personnel and the national guard to administer the vaccines. Focus on schools: Biden also instructed states to start vaccinating teachers so that schools can reopen. Many states are already doing this. The White House has set a goal to vaccinate all teachers by the end of March. “We are going to treat personal learning as an essential service that it is. And that means getting the essential employees who provide that service – educators, school staff, child assistants – to vaccinate them immediately,” said Biden on Tuesday. The federal government plans to allow teachers to take injections 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 policy database from the Kaiser Family Foundation. In the 2017-2018 school year, there were about 4 million teachers in the United States, according to the National Center for Education Statistics. The United States recently delivered about 1.8 million doses of the COVD-19 vaccine per day. Some days are well over 2 million doses, according to the Centers for Disease Control and Prevention. The US government is sending about 2.4 million doses to retail pharmacies each week, Andy Slavitt, a consultant for COVID-19 at the White House, said on Twitter. Reading list: the best stories on the health supply chain A needle-free Covid-19 vaccine? These companies are on the case — Wall Street Journal Freight pilots are flying Covid-19 vaccines around the world – and asking for their turn to be vaccinated — STAT Amazon Care, a healthcare provider, has quietly filed the paperwork to operate in 17 more states —STAT Merck’s COVID’s manufacturing agreement with the US government goes far beyond the J&J vaccine – the pink sheet Thanks for reading. Send an email to [email protected] if you have questions, compliments or complaints. If this email was forwarded to you, sign up here. 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