Prescription drug shortages have become increasingly common in recent years and outbreaks such as COVID-19 or natural disasters place increasing pressure on our supply chains. Advocates claim that over-reliance on foreign pharmaceutical products is a big reason for these drug shortages, as demonstrated by the impact COVID-19 has had on manufacturers in China and India. However, drug shortages can occur for many reasons, including manufacturing and quality problems, delays and discontinuations. Manufacturers are supposed to provide the FDA with drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages. A drug receives ‘resolved’ status when the FDA determines that the market is covered, based on information from all manufacturers. The market is considered covered when supply is available from at least one manufacturer to cover total market demand.

If a company is the sole supplier of a drug, it is required to notify the FDA six months before it anticipates a shortage of that medication. This important time-period is needed for physicians to acquire substitute medications before a crisis occurs. However, this rule is not enforced and companies do not face any legal consequences if they fail to notify the FDA in time to prevent a drug shortage. Health advocates say these shortages can cause great harm to patients who depend upon these drugs. Besides being forced to use inferior substitutes, there are no studies that predict the effectiveness of a drug that is substituted in the middle of a regimen.

Proposed Legislation: Reintroduction of H.R.70 - Securing America’s Medicine Cabinet Act of 2021
Prospective Sponsor: Rep. Vern Buchanan (FL)