U.S. Shutdown - What Does It Mean For The Pharma Industry?

It is the longest shutdown in U.S. history and it hasn't ended yet. For 34 days all non-essential government tasks have been stopped. More than 420,000 employees of the state are working without being paid, and another 380,000 employees have been sent home. The U.S. Food and Drug Administration (FDA) is one of the authorities that is forced to cease most of its work. While vital activities are still being carried out, many routine inspections cannot be performed. This raises the following question: How does the shutdown affect pharma quality?

Many times in history, the US government has been forced to cease its work. This so-called shutdown happens if the US Congress cannot agree on a budget bill by a certain date. As a result, all non-essential government services are stopped immediately as payments are suspended. Many offices, authorities, museums and national parks remain partially or completely closed. Essential services related to safety or health are usually continued. Therefore, the shutdown does not affect agencies such as the police, the FBI, emergency services, United Stated Border Patrol, Transportation Security Administration (TSA), air traffic control and the legal system. As the FDA plays an important role to ensure pharma quality, we have found answers for the frequently asked questions.

Is the FDA completely unable to act?

Not completely. During the shutdown, the authorities will continue to pursue their vital activities in order to guarantee that public health is not compromised. Activities that are performed include:

  • reacting to emergencies such as responding to outbreaks
  • supporting high-risk food and medical product recalls
  • screening food and medical products that are imported to the U.S.

During the shutdown the FDA stops routine inspections, research activities and applications for new drugs.

How does the shutdown affect pharmaceutical companies?

Not all areas for which the FDA is responsible are affected by the shutdown. As drug approvals, inspections of drug-producing facilities, and the regulations of tobacco products are being mostly paid by user fees, their activities can continue for some time. However, the longer the shutdown lasts, the more likely that FDA review of applications will be delayed. This causes delays in company launch plans and affects business strategies.

What pharma companies should consider

Pharmaceutical companies with applications on file should try to stay in contact with the FDA in order to determine if deadlines can be met. In the worst-case, launch plans need to be reviewed or postponed. Once the shutdown is over, it will take a while until everything gets back to normal. There will be a huge backlog that needs to be cleared. Therefore, pharmaceutical companies must expect delays even after the shutdown.

References:

https://www.fda.gov/AboutFDA/WorkingatFDA/ucm629100.htm

https://www.pharmamanufacturing.com/articles/2019/the-shutdown-and-the-fda-what-pharma-companies-need-to-know/

https://www.gmaonline.org/blog/how-the-government-shutdown-affects-the-cpg-industry/