SOCMA and EFCG Urge for Reform in FDA Inspections of Foreign Drug-Manufacturing Facilities - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

SOCMA and EFCG Urge for Reform in FDA Inspections of Foreign Drug-Manufacturing Facilities


ePT--the Electronic Newsletter of Pharmaceutical Technology

The Bulk Pharmaceutical Task Force (BPTF) of the Society for Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) of the European Chemical Industry Council (CEFIC) are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient (API) manufacturing sites with the cost borne by those sites being inspected. Both organizations have indicated a willingness to pay fees for these inspections when performed on their member-owned facilities that are located outside the United States.

In comments recently submitted to FDA, BPTF and EFCG contend “FDA is unable to keep up with globalization of the drug industry,” according to a Mar. 8, 2011, SOCMA press release. “As a result, inspections in high-risk regions like China and India are almost nonexistent when compared to the US and Europe, posing a risk to public health,” according to the release. BPTF and EFCG say that to have a sustainable foreign-inspection program, a fee for each foreign compliance inspection carried out by FDA should be collected.

BPTF and EFCG also are calling for the development of an electronic database to capture accurate information on API manufacturers selling product into the US.  Registration fees, sufficient to cover the cost of developing, compiling and maintaining this database, were suggested. “Having accurate information about API manufactures is critical to ensuring a safe drug supply,” said SOCMA in its release.

BPTF and EFCG are sector groups of SOCMA and CEFIC, respectively, and whose members include manufacturers of APIs, excipients, and intermediates.

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.
24%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
10%
All of the above.
44%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here