This is an excerpt from the May 6, 2021 edition of Medically Necessary, a health care supply chain newsletterSubscribe here.

The decision: On Wednesday, U.S. Trade Representative Katherine Tai announced that the Biden administration supports waiving intellectual property rights for COVID-19 vaccines. 

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said, according to a statement.

U.S. support doesn’t automatically end the intellectual property rights for COVID-19 vaccines. The World Trade Organization, which has been considering this move for months, will make the final call.

The supporters: Supporters of the proposal argue that removing the barrier of intellectual property rights will make it easier to boost the production of COVID-19 vaccines. 

World Health Organization Director-General Tedros Adhanom Ghebreyesus called the decision a bold move that would end the pandemic faster. 

“I commend the United States on its historic decision for vaccine equity and prioritizing the well-being of all people everywhere at a critical time,” he said, according to a press release. “Now let’s all move together swiftly, in solidarity, building on the ingenuity and commitment of scientists who produced life-saving COVID-19 vaccines.”

U.S. Surgeon General Vivek Murthy called the move “a critical step toward ensuring the world can produce enough vaccines to protect all people.” 

“The only way global pandemics end is with global cooperation and mutual aid,” Murthy tweeted.

The critics: Drugmakers and others strongly disagreed with the idea that intellectual property protections are slowing the pace of vaccine production. 

“This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials. These are the real challenges we face that this empty promise ignores,” Stephen Ubl, Pharmaceutical Research and Manufacturers of America CEO said in a statement.

On a conference call with investors Thursday morning, Moderna CEO Stéphane Bancel argued that even if other companies had unfettered access to Moderna’s intellectual property it would still take years to scale up manufacturing.

“There is no mRNA manufacturing capacity in the world. This is a new technology. You cannot go hire people who know how to make mRNA. Those people don’t exist,” he said. “Even if all those things were available, whoever wants to do mRNA vaccines will have to buy the machine, invent the manufacturing process … get the product approved and scale manufacturing. This doesn’t happen in six, 12 or 18 months.”

On Twitter, Rajeev Venkayya, Takeda’s head of vaccines, argued that transferring the technological knowledge from one company to another would require an enormous amount of effort, and vaccine experts from successful companies don’t have the bandwidth to do that.

He pointed out that raw materials for the vaccine have also slowed production and waiving IP protections does nothing to solve that issue.

What’s next? WTO Director-General Ngozi Okonjo-Iweala said she welcomes a discussion about waiving intellectual property rights and encouraged supporters to bring a proposal to the table as soon as possible.

“It is only by sitting down together that we will find a pragmatic way forward — acceptable to all members — which enhances developing countries’ access to vaccines while protecting and sustaining the research and innovation so vital to the production of these life-saving vaccines,” Okonjo-Iweala said in a statement.

FDA outlines plans to deal with inspection backlog

(Credit: Food and Drug Administration)

The plan: Facing a backlog of inspections for drug production facilities, the Food and Drug Administration says it will prioritize the most urgent cases and use new techniques to catch up.

“This plan provides the public with a transparent picture of both the successes and challenges we’ve faced in these areas over the past year, as well as our plan moving forward,” Acting FDA Commissioner Janet Woodcock said in a release

A new report from FDA quantifies the effects of the delayed inspections and details strategies for chipping away at the backlog, such as video inspections, documentation requests and agreements with foreign regulators. 

Backstory: In March 2020, FDA paused most inspections of drug production facilities to protect inspection staff during the COVID-19 pandemic. 

Domestic inspections restarted in July but were limited to high-priority situations. Normal international inspections didn’t resume until October.

During the pandemic, the agency continued surveillance of drug quality by requesting documentation from drug producers and partnering with regulators in other countries.

The Government Accountability Office found that FDA wasn’t able to complete more than 1,000 of its planned surveillance inspections for fiscal year 2020.   

According to GAO, the backlog means there’s a greater risk that drug manufacturing facilities will go uninspected for long periods, increasing the risk of poor-quality drugs entering the supply chain. 

While FDA normally uses less than a third of inspection resources for the highest-risk facilities, GAO estimates the agency may need to use more than half its resources on high-risk locations by 2022.

The update: From October 2020 to March 2021, FDA conducted 79 inspections, both domestically and abroad, for drug production facilities, according to the new report

That’s much lower than normal. Since 2012, FDA has conducted more than 1,600 inspections of drug production facilities per year. 

Since 2015, most inspections have occurred abroad, where the majority of drug production facilities serving the U.S. market are located. 

(Credit: FDA)

The impact: FDA reports that postponed inspections delayed regulatory approval for 48 drug production facilities. 

However, the agency only classified six of those delayed applications as critical. Inspections for those applications should be completed before October.

The agency prioritized many pre-approval inspections, especially for products for which the inspection was the final piece needed for approval. 

Prioritizing pre-approval and for-cause inspections meant that surveillance inspections — essentially spot checks to ensure manufacturers don’t have quality problems — were often postponed.

The challenge: Now, FDA is hoping to catch up on the postponed inspections. The agency’s ability to do that will depend on the course of the pandemic.  

More than 850 drug producers, 2,400 medical device makers and 110 facilities producing biologics need surveillance inspections by October, according to the report. 

In a best-case scenario, in which FDA inspectors resume normal operations by July, FDA estimates it can complete 26% of inspections needed for human and animal medical products, a category that also includes medical devices and animal drugs. 

Inspections for drugs, biologics and medical inspections only make up about 15% of FDA’s inspection backlog. More than 75% of delayed surveillance inspections are for facilities that produce human food. 

In a worst-case scenario, in which new variants or other problems prolong the pandemic, FDA plans to basically stay on its current path, conducting only mission-critical inspections. That would only add to the backlog. 

FDA has a twofold strategy for catching up on inspections: Adapt and prioritize.  Adapting includes increasing the use of video monitoring tools, document requests and agreements with foreign regulators. Prioritizing means following standardized criteria when deciding which facilities to inspect first.

In general, FDA is prioritizing inspections related to high-priority products, the COVID-19 pandemic or serious violations. Surveillance inspections get the lowest priority. 

What’s next? Despite the scale of the challenge, FDA also framed the pandemic as a learning opportunity.

The agency discovered that in many cases it could accomplish some quality surveillance tasks by simply requesting documents from manufacturers. 

The agency has now issued warning letters to several manufacturers based solely on document requests, according to Regulatory Focus.

FDA is also expanding its workforce, and the agency hinted that it’s exploring “next-generation” tools to speed up inspections, but didn’t specify what those were.