Exclusive-Thermo Fisher plant making new RSV drug violated FDA rules, documents show Reuters
Written by Patrick Wingrove
(Reuters) – One of the largest U.S. drug companies owned by Thermo Fisher Scientific (NYSE: ) over the past 10 years has repeatedly violated rules meant to ensure that drugs are not contaminated, FDA documents show, including twice this year. .
The most recent US Food and Drug Administration inspection of Thermo Fisher's Greenville plant in May identified problems with the production of the respiratory syncytial virus drug Beyfortus, an antibody therapy from AstraZeneca (NASDAQ:) and Sanofi (NASDAQ:) for infants and toddlers.
These issues were resolved to the FDA's satisfaction, the FDA and Sanofi said. There is no evidence that these manufacturing defects have caused harm to patients.
The 1.7-million-square-foot plant makes about 40 different drugs, according to the FDA's national drug list, including life-saving hospital and pharmacy drugs and Novo Nordisk's (NYSE: ) weight-loss drug Wegovy. Thermo Fisher bought the plant in 2017 through its acquisition of contract manufacturer Patheon.
Growth in obesity drugs and complex biologic therapies is increasing demand for US contract manufacturers such as Thermo Fisher. But two manufacturing experts say the industry's 10-year audit record gives them cause for concern about the company's quality control practices.
“There are a lot of problems with organizational culture. They don't look long term and have a fix-it-when-they-get-caught-against-prevention culture,” said David Talmage, vice president of education at the Parenteral Drug Association. which provides training on sterile manufacturing best practices.
An FDA inspection of the Beyfortus production line found that required manufacturing procedures did not extend to areas such as ensuring that certain equipment was adequately sterilized, according to a report obtained by Reuters through a Freedom of Information Act (FOIA) request.
A spokesman for Sanofi, which markets Beyfortus in the US where it was approved last year, said all of the FDA's findings were addressed and reviewed by the regulator. The FDA approved doses of Beyfortus before they left the plant for sale, a spokeswoman said.
Sandy Pound, chief communications officer at Thermo Fisher, said the company participates in more than 1,000 regulatory and customer surveys every year and takes regulators' feedback seriously. He did not comment on the details of the FDA audit.
FDA REPORT
The FDA report noted 17 deficiencies during the Beyfortus study including inadequate visual inspection of any particulate matter floating in the injectable drug and problems with how staff handled sterile components.
One problem identified was that Thermo Fisher did not provide studies to support how they measure and set possible bubbles in injectable drugs. Such bubbles can cause fatal blood clots in the veins or arteries.
The FDA said in a statement that it had inspected the plant for reasons related to certain FDA-approved products at the site and had not taken or recommended regulatory or enforcement action, saying it was not confirmed at this time.
Many of the concerns raised in the FDA's manufacturing audit are being resolved, as it were, by settlement with the company. The FDA can take action when companies do not cooperate or make corrections quickly enough or satisfactorily.
The agency said the manufacturer has provided information on several issues including bubble size control and information on acceptable bubble sizes from a safety perspective. The FDA added that the agency “has adequately addressed its concerns.”
The FDA did not comment when asked if patients were harmed by the lapse.
The drugs, which were found to be problematic in five other FDA inspections from 2014 to February this year, were not identified in regulatory reports obtained by Reuters. We have tested this plant at least 10 times in the last 10 years.
The FDA conducts thousands of audits a year but the time between plant visits varies. It prioritizes plants for sterile production tasks like this.
Three experts who reviewed the FDA documents said they were concerned that workers did not follow procedures to prevent contamination, including adequately disinfecting equipment used to seal drugs and prevent leaks.
Steven Lynn, former head of the FDA's Office of Productivity and Product Quality who is now a compliance consultant, said problems with Thermo Fisher's blister size test are one of the biggest concerns.
TERMS TOO
The FDA first examined the plant this year in February, according to a separate report obtained by Reuters through FOIA, targeting the COVID and flu vaccines, which are given in the fall when respiratory infections are around.
The administrator returned in May to investigate the production of Beyfortus, Moderna (NASDAQ:) vaccine for COVID-19, and two flu vaccines made by Australia's CSL (OTC:), according to a source familiar with the matter who was not authorized to speak.
Moderna and CSL both said they were not manufacturing vaccines at that facility at the time of the FDA visit.
Thermo Fisher's Greenville plant received $49 million from the US Department of Defense in 2020 to help make COVID vaccines and is one of the latest government-subsidized plants found to fall short of FDA production standards.
Thermo Fisher's manufacturing business, which operates as Patheon and includes more than 60 plants in 24 countries, accounts for about $8 billion, or 19%, of its $42.8 billion in annual revenue.
Thermo Fisher competes with contract manufacturing companies Lonza and Catalent (NYSE: ), which has agreed to be acquired by Novo Holdings.
“Contract manufacturing will likely continue to drive Thermo's market growth (in part) due to market demand,” said Deutsche Bank analyst Justin Bowers.
