FDA Moves to Curb Drug Shortages - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Moves to Curb Drug Shortages



As required by the FDA Safety & Innovation Act (FDASIA) of 2012, FDA issued a Strategic Plan for responding to drug shortages Oct. 31, 2013, plus a proposed rule for how manufacturers should notify the agency of an interruption or discontinuation in production of a medically important therapy. The rule expands notification to a broader spectrum of drugs, including biologics, and advises on dealing with suppliers and contract manufacturers.

The Strategic Plan spells out how FDA can better respond to shortage situations and how manufacturers should avoid supply problems: build up inventories before making production changes, improve communications with contract manufacturers, and consider upgrades for aging facilities. There is support for incentives to companies that adopt manufacturing quality improvements and risk-based approaches, but few specifics on rewards for doing so.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality

Click here