Balancing Act - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Balancing Act
Perhaps Congress can help FDA meet its multiple oversight demands.


Pharmaceutical Technology


A widely cited statistic holds that two-thirds of all drug withdrawals occur within the first three years of release, so several organizations—Consumers Union and the Institute of Medicine among them—have suggested imposing a two- or three-year moratorium on these ads following a drug's release. That would give drug manufacturers and regulators time to gather accurate safety data about the drug and, said Consumers Union, "result in a major reduction in the use of drugs eventually found unacceptably risky."

With Senate approval, PDUFA will now go to the House for a vote—expected in July. Perhaps between now and then, US representatives will impose the advertising moratorium and make the bill one that truly protects the public from unsafe drug claims as well as unsafe drugs.

Michelle Hoffman is editor in chief of Pharmaceutical Technology,


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here