"If we want to reduce incidents of drug shortages and astronomical price increases, we need to be bold," says Girish Malhotra, PE, EPCOT International.
Malhotra proposes what may be an unpopular potential solution to the growing problem of drug shortages, and the resulting price hikes.
According to Malhotra, modified elements of Orange Book (the publication which identifies all drug products approved on the basis of safety and effectiveness by the FDA) and FDASIA can be used to reduce drug shortages and lower high prices. "One potential solution could be to have companies submit to the regulatory bodies their expected production plan for the life saving drugs. Companies are not going to like this but it would cajole companies to improve their operations," says Malhotra.
Further, if companies fail to correct supply chain issues and do not make the effort to assure proper raw material and equipment availability for a drug, they would be publically de-listed -- losing their evergreen rights and production and marketing privileges.
Read Girish Malhotra's full blog post and share your thoughts.