The Association for Accessible Medicines (AAM)’s recently published white paper, “Drug Shortage: Causes & Solutions,” is an important analysis of the diverse and complex issues underlying the staggering level of medicine shortages, as well as the extent to which these issues endanger the supply of generic medicines. The myriad of challenges involves a broad number of areas, including patent law, corporate consolidation, marketing and pricing disincentives, global economy constraints, supply chain vulnerabilities, government policies, and quality manufacturing challenges. Medicine shortages will continue to grow if these issues are not addressed.
This is a pressing national security issue.
There are several interesting solutions contained in the AAM white paper. Some of these include:
- building reserves of critical medicines;
- improving generic manufacturing capacity and compliance, including increasing FDA’s ability to expedite facility reviews;
- increasing drug shelf life; and
- expediting drug approvals.
It will be great to see the legislative and executive branches of government to address these wide-ranging concerns. I am encouraged to see the recommendations provided by AAM. I hope this is not just words on paper, but the beginning of a plan that the public and private sectors will work together to implement. Public health matters.
QxP Vice President Christine Feaster is a 20+ year veteran in pharma quality assurance. Prior to joining QxP, Christine was a vice president of U.S. Pharmacopeia.
Also by Christine: “Quality is Number One, Even When Trying to Address Supply Chain Issues.”