FDA Opts for Public Safety Over Pain Med Access
April 19th, 2013 // 3:54 pm @ jmpickett
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FDA decided it seems to come down on the side of cutting down the abuse of opoids, rather than encourage more availability of these low cost painkillers. FDA is decided to not allow generic versions of OxyContin, according to a CDER decision this week. This drug formulation was pretty simple for counterfeiters to make illegally. FDA’s goal would appear to be to slow the serious epidemic of Rx drug abuse that the US is experiencing.
FDA’s recent decision on this matter means that the market is left open for a newer version of the drug by Purdue Pharma. FDA believes the Purdue Pharma drug has aspects that make it harder to abuse through snorting or injection.
FDA Works Closely With Purdue on OxyContin Abuse Risks
Purdue ceased shipping the original OxyContin three years ago. At that time, FDA gave its approval to the safer and reformulated drug. Purdue started a marketing campaign to stop generic versions of the original drug. The patent on that drug expired in April 2013. After a lot of thought, the agency agreed and stated that it would not allow any generic versions of OxyContinER. FDA also has updated all labeling of the new version of OxyContin to fully support the new deterrent factors.
- April 25 – How to Survive PREDICT – FDA’s New Import Screening Program
- April 29 – Audit Your Lab Like an FDA Auditor – A Roadmap to cGMP Lab Compliance
Drug makers that produce generics and some doctors stated that patients should have access to pain drugs that cost less. But this would mean there is a prospect of inexpensive generic painkillers flooding the American market that are easy to abuse. This had strong opposition from US officials that want to control the abuse of illegal prescriptions.
It is possible that FDA might give its approval to other types of oxycodone drugs that are extended release in nature with features that make them resistant to abuse. However, the new Purdue product has a patent that lasts until 2025.
FDA has requested that the pharmaceutical company do postmarketing studies of the new OxyContin to see if there is a reduction of abuse of the drug. FDA also is working on final guidance that will provide approaches for drug makers to come up with drugs that are harder to abuse. Several generic drug makers were ready to come out with versions of the old drug, so they could get a piece of the huge $10 billion painkiller drug market in the US.
Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:
- April 23 – Spend $500K on Compliance or $300 Million on Consent Decree? – Essential cGMP Compliance Tips for Sr. Management
- April 25 – How to Survive PREDICT – FDA’s New Import Screening Program
- April 29 – Audit Your Lab Like an FDA Auditor – A Roadmap to cGMP Lab Compliance
- April 30 – How to Prepare Yourself for 21 CFR Part 11 Inspections
- May 1 – Avoiding Warning Letter Disasters With a Strong cGMP and GCP Quality Agreement
- May 2 – Avoid the CDRH eCopy Confusion – How to Prepare a Compliant eCopy Submission
- May 7 – FDA Recall Chief Update – How to Design a Bulletproof Recall Strategy
- May 15 – FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters
Updated Daily – Read our latest FDA, cGMP Compliance News
