FDA's Drug Safety Plan to Increase Post-Market Safety - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA's Drug Safety Plan to Increase Post-Market Safety


ePT--the Electronic Newsletter of Pharmaceutical Technology

Untitled Document

Rockville, MD (Apr. 3)—In an ongoing effort to secure the safety of prescription drugs, the US Food and Drug Administration has released its draft five-year drug safety plan under the Prescription Drug User Fee Act (PDUFA). The plan expands from previous years' commitments to accelerate the drug evaluation process to expanding post-market safety evaluations and prevention. With the drug safety plan, FDA intends to reduce medication errors, increase staff, improve existing tools, develop new tools, gain access to new databases, and adopt new standard operating procedures.

Included in the draft [deleted PDUFA] are FDA's plans to evaluate current adverse event collection and to develop new reporting software and collection practices. FDA states that it is committed to identifying epidemiology best practices and will produce a new guidance to be finalized in FY 2011. The development and validation of risk management and risk communication tools are also planned. An evaluation and eventual upgrade of FDA's review of new drug trade names will be performed.

In an effort to increase resources, FDA intends to hire new staff and obtain access to databases that will enable increased post-marketing surveillance and epidemiology. Staff hires will include safety evaluators, risk management experts, medication error experts, and regulatory project managers. The Center for Drug Evaluation and Research (CDER) will expand the Office of Surveillance and Epidemiology (OSE) with new staff "distributed across the office, strengthening the capability and capacity of the organization in its post-marketing safety role." The Center for Biologics Evaluation and Research (CBER) will also increase its staff.

Under PDUFA IV, drug safety has an annual allocated budget of $29.29 million for FY 2008 that will increase each year with annual inflation. FDA has also been authorized by Congress to collect additional user fees to supplement the program's budget. FDA plans to increase user fee revenues from FY 2008 to FY 2012 in post-market activities from $13 million to $16 million; $7 million to $9.5 million in epidemiology best practices and new data acquisition; risk management and risk communication will increase from $4 million in to $5 million; and new drug trade name review will increase from $5.3 million to $6.5 million.

FDA's draft of PDUFA IV Drug Safety Five-Year Plan is available for download here.

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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here