Taking Action to Reduce Drug Shortages
“Five years ago it was rare for us to hear from a hospital, a patient, a supplier, a pharmacist, about this issue. Now, we are constantly hearing from people about drug shortages.”
The recent shortage of vincristine - a chemotherapy drug essential in the treatment of most children with cancer - was not an isolated event. Unfortunately, drug shortages have become all-too-common in recent years and pose a real threat to the lives of patients in treatment.
We’ve been keeping you updated on efforts to resolve the immediate crisis of the vincristine shortage and some new initiatives aimed at addressing the systemic problems that cause these shortages in the first place.
Here’s the latest — and how you can help:
The Food and Drug Administration (FDA) issued a comprehensive report on drug shortages in October of 2019 that identifies several root causes and identifies potential solutions, including improving data sharing, lengthening expiration dates, incentivizing drug manufacturers to invest in quality management maturity for their facilities, and promoting sustainable private sector contracts to ensure a reliable supply of critical drugs. We shared more about this report in an earlier blog post, here.
In late October, Senate Bill 2723 - the Mitigating Emergency Drug Shortages (MEDS) Act - was introduced. The MEDS Act calls for FDA to speed facility inspections and application reviews for generic drugs in short supply, make bulk manufacturers disclose supply disruptions, direct makers of life-supporting drugs to develop back-up manufacturing plans, and recommend ways Congress could incentivize manufacturers to enter the market to avert shortages. We believe this legislation would help alleviate future drug shortages, including those in pediatrics, and are supporting this legislation. Now you can join in the effort by writing a letter to your Senators using our Action Alert. Take Action →
The House of Representatives also introduced a bill in October (H.R.4866) that would allow FDA to create National Centers of Excellence in Continuous Pharmaceutical Manufacturing. The designated universities would work with FDA and industry to develop and implement ‘continuous manufacturing technology.’ This emerging technology allows product quality to be precisely controlled, reduces challenges in scaling up production, can more readily produce ranges of drug strengths and doses, and requires less physical space.
Several lawmakers, including Senator Klobuchar (MN), Representatives Axne (IA), Gonzalez (OH), and Higgins (NY) - have taken action on this issue, writing letters to FDA and HHS asking about agency efforts to address and prevent drug shortages. It is critical that our community keep speaking up so that Congress and these federal agencies know we are paying attention and expecting to see progress and outcomes.
Dr. Stephen Hahn, nominee to be the next FDA Commissioner, stated in his confirmation hearing that he is committed to working with Senator Collins on solving the vincristine shortage issue. As an oncologist, Dr. Hahn said he understood the gravity of the vincristine shortage and plans to address drug shortages in a proactive manner.
