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Medically Necessary: FDA way behind on facility inspections

This is an excerpt from the March 4, 2021 edition of Medically Necessary, a health care supply chain newsletterSubscribe here.

Good afternoon. Medically Necessary is a newsletter by Matt Blois about the health care supply chain — how we get drugs, devices and medical supplies to health care providers and patients.

FDA way behind on facility inspections

The problem: The U.S. Food and Drug Administration largely stopped conducting surveillance inspections — periodic evaluations of manufacturing plants to ensure drug quality — during the coronavirus pandemic.

  • The FDA only conducted three surveillance inspections of foriegn facilities between March and October of 2020, compared with more than 600 during the same period a year earlier. 
  • The agency conducted about 1,000 international inspections per year from 2016 through 2019.
About 74% of manufacturers making active ingredients and 54% of facilities making finished drugs for the U.S. market are located outside the country. (Credit: Government Accountability Office)

Why it matters: A recent report from a team at Johns Hopkins University’s school of public health says postponed FDA inspections contributed to drug shortages last year, including drugs critical for treating COVID-19 patients.

The delays have also slowed the process for approving new drugs. The FDA recently deferred or denied approval for six drugs because it couldn’t inspect manufacturing facilities, according to this must-read story from Politico

  • A guidance document for drug manufacturers notes that the FDA would try to approve applications for manufacturing facilities by gathering information remotely, but if an inspection is needed they may need to delay a decision.

The past: The GAO has criticized the FDA’s oversight of “an increasingly global pharmaceutical supply” for years, according to the GAO report. 

  • The GAO determined the FDA wasn’t conducting enough foriegn inspections in both 1998 and 2008. The agency made some recommendations and increased inspections. 
  • Inspections started to fall again in 2016. FDA officials said that was because they didn’t have enough staff to keep up, according to the GAO. 

The pandemic: While the FDA halted many inspections, the agency argued in an annual report from its Office of Pharmaceutical Quality that it still achieved its most important goals.

  • The agency continued some pre-approval inspections — needed before a facility starts producing a drug — by requesting documentation or relying on inspections by European regulators. The FDA used those methods for more than 150 pre-approvals.
  • In 2020, the FDA approved applications for production of 942 generic drugs, down only slightly from 2019.
  • The FDA also told drug producers that manufacturing changes for 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 in-person inspections, FDA did look 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 allowed European regulators to vouch for the quality of drug manufacturers all over the world. Normally, the FDA only accepts those regulators’ inspections of European facilities.
  • It beefed up inspection and testing of products as they entered the U.S., which caught dozens of drug quality problems.

The future: The current backlog of inspections could also gum up the drug supply chain for years to come. 

  • The GAO report notes that the FDA wasn’t able to complete more than 1,000 of its planned inspections 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 that goal, increasing the risk of poor-quality drugs entering the supply chain. 

Each year, the agency creates a list of facilities that need inspection. The highest-risk locations — those that have never been inspected or haven’t been inspected in five years — get priority. Remaining resources go toward other facilities. 

  • Previously, the FDA spent less than a third of its inspection resources on the highest-risk facilities, allowing the agency to stay ahead of the curve. By 2022, the GAO estimates the FDA will need to use the vast majority of its resources on high-risk facilities.   
(Credit: Government Accountability Office)

Back on the horse: By October, the FDA started conducting some international inspections once again.

  • FDA conducted nine pre-approval inspections in China during late 2020 and early 2021 but didn’t complete any surveillance inspections.
  • The agency started inspections in India in January, completing two by Feb. 25.

Catching up: Like a college student pulling an all-nighter after procrastinating all semester, the FDA is looking for creative ways to cram in inspections after falling behind. 

The FDA plans to continue using the tools, such as reports from European regulators and document reviews, that helped it carry out its work during the pandemic, but it’s also exploring creative options to speed things up.  

  • The agency is researching whether it could use videoconferencing 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, like Australia or Japan, to stand in for FDA inspections during pandemics or other emergencies.   

The Office of Pharmaceutical Quality’s annual report also says the agency is developing a new risk management strategy to prepare for future disruptions. It’s not clear what that strategy looks like.

Biden promises vaccine doses for all U.S. adults by May, prioritizes teachers

(Photo: Flickr/Gage Skidmore CC BY-SA 2.0)

Supply boost: The Biden administration is promising to have enough doses of COVID-19 vaccines to inoculate every adult in America by May. However, actually vaccinating every adult will be a different challenge.

  • “It’s not enough to have the vaccine supply.  We need vaccinators — people to put the shots in people’s arms, millions of Americans’ arms,” President Joe Biden acknowledged during a press conference on Tuesday.

Biden highlighted the federal governments efforts 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 directed states to start vaccinating teachers so schools can reopen. Many states are already doing that. The White House set a goal of vaccinating every teacher by the end of March. 

  • “Let’s treat in-person learning like an essential service that it is. And that means getting essential workers who provide that service — educators, school staff, childcare workers — get them vaccinated immediately,” Biden said on Tuesday.

The federal government plans to allow teachers to get shots at retail pharmacies to achieve that goal.

The numbers: There are still 18 states that haven’t made teachers eligible for early vaccines, according to a Kaiser Family Foundation policy database.

  • The U.S. has recently been delivering about 1.8 million COVD-19 vaccine doses per day. Some days are well above 2 million doses, according to the Centers for Disease Control and Prevention.

Reading list: The best stories about the health care supply chain

  • A Covid-19 Vaccine Without a Needle? These Firms Are On the Case The Wall Street Journal
  • Freight pilots are flying Covid-19 vaccines around the world — and calling for their turn to be vaccinated STAT
  • Amazon Care’s health provider has quietly filed paperwork to operate in 17 more states STAT
  • Merck’s COVID Manufacturing Deal With US Government Goes Well Beyond J&J Vaccine The Pink Sheet

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Matt Blois