FDA Encourages Whistleblowers, Just Not Its Own - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

FDA Encourages Whistleblowers, Just Not Its Own
FDA's treatment of whistleblowers lacks internal consistency.

Pharmaceutical Technology
Volume 36, Issue 3, pp. 12

Amy Ritter
As part of Ranbaxy's recently announced consent decree, the company is required to set up a program whereby whistleblowers can come forward with information related to potential violations of the Food, Drug, and Cosmetic Act. According to the decree, Ranbaxy must, within 75 days, establish a phone line and a system to receive and maintain submissions from individuals wishing to report suspected violations. The submissions are required to be confidential, there should be no retaliation, and a good-faith effort must be made to investigate any allegations.

But what's good for Ranbaxy has been causing some discomfort for FDA.Whistleblowers from FDA's Center for Devices and Radiological Health have sued the agency over allegedly being harassed and dismissed after publicly questioning the agency's approval methods for devices. The suit brought by the whistleblowers alleges, among other things, that FDA improperly read private emails to support a case for dismissing the plaintiffs. This prompted a letter to FDA commissioner Margaret A. Hamburg from Senator Charles Grassley (R–IA), in which he castigates the agency for perceived mistreatment of the whistleblowers, and includes a series of questions for the agency to answer to clarify its actions with respect to email monitoring.

Among the questions to the agency, Grassley asks, "What steps have you taken to reassure employees that they have a right to direct communications with Congress?" The answer to that question is an important one. FDA should expect no less from itself with respect to whistleblower protection than it demands of others.

Amy Ritter is a scientific editor of Pharmaceutical Technology.


blog comments powered by Disqus
LCGC E-mail Newsletters

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

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here