FDAzilla Blog >> Working Smarter with the FDA

FDA, Me and Maybe the Mafia—A True Story

17 May

In honor of FDA Matters’ third anniversary, I am sharing a personal story. It reflects FDA’s history as a struggle of competing interests—where sometimes reasonable people disagree, often vehemently, while at other times it is obvious that indifference or greed are the driving forces. Continue reading →

Safety and Efficacy Standards: Innovative Approaches to Radical Ideas

8 May

FDA is in the midst of its quinquennial* (five year) review from Congress as part of the user fee reauthorization cycle. Lots of proposals are on the table and FDA Matters agrees with some and disagrees with others. So far though, there doesn’t seem to be anything that would pull FDA apart or create an agency that cannot act with integrity.  Continue reading →

OMB, HHS, or FDA: Who Really Makes FDA’s Decisions?

24 Apr

OMB, White House staff, and the Secretary of HHS review many FDA decisions and their oversight sometimes alters FDA’s positions. This was chronicled in a recent NY Times article and generated a number of editorial comments criticizing anyone tampering with FDA’s integrity. However, the individuals named in the article have the authority (on behalf of the President) to question FDA’s judgments.   Continue reading →

Taming the Monster – The Economic Benefits of Adaptive Trials

12 Apr

There is no question that pharmaceutical companies large and small are feeling the financial pressures associated with deploying large clinical trials. Traditional trial designs can be overly cumbersome and expensive, particularly when applied to large populations of patients over the course of a lengthy investigation. This inescapable fact has lead many investigators to consider alternative pathways to gathering the safety and efficacy data they need for regulatory purposes, with adaptive trials leading the way. Continue reading →

Today Show Hypes Medical Device Reprocessing Safety Issues

10 Apr

A recent segment on the Today show highlighted public concerns regarding hospital acquired infections – specifically, those that can be contracted from medical devices and surgical instruments. The report presented the case that even if proper sterilization processes are followed, there remains a strong chance that surgical equipment will be contaminated with blood, tissue, and fluids from previous patients. Continue reading →

Proposals to Speed-Up Drug Approvals: Not Created Equal

3 Apr

An important part of the 2012 user fee reauthorization cycle is Congressional efforts to push FDA toward approving drugs and biologics more rapidly. Most of industry and a large number of patient groups agree. Proposals to speed up FDA are already in play. Continue reading →

FDA Progress “At Risk:” An Update on Funding and a Call to Action

29 Mar

FDA Matters’ State of the FDA—January 2012 identified agency funding as the greatest threat to the FDA’s future.  The agency received a very small increase in FY 12 appropriated funding, reflecting the severe budgetary pressure on all U.S. federal agencies. That pressure continues and FDA faces potential cuts in FY 13 (starting October 1, 2012). Continue reading →

The FDA Matters “Guide to the User Fee Reauthorization Process”

27 Mar

The prescription drug (PDUFA) and medical device (MDUFA) user fee programs, which run for 5 years, must be renewed by September 30 of this year (last day of the current fiscal year).  House committee staff has just released a 205-page first draft of reauthorization legislation. The Senate has starting releasing drafts on specific issues and has a March 29 hearing scheduled. Continue reading →

Drug Shortage: A Story of Self-Inflicted Management Tragedies

22 Mar

My blood boils when I read an article such as the one that appeared in the New York Times yesterday entitled Supply of a Cancer Drug May Run Out Within Weeks, by Gardiner Harris. This is one of many articles that has appeared lately about the mounting crisis of drug shortages across the country. This time it is the drug to treat acute lymphoblasic leukemia, which most often strikes children ages 2 to 5. Continue reading →

FDA Doubles Medical Device User Fees

20 Mar

Is the pathway to quicker medical device regulatory approval or clearance to be found through the establishment of higher fees on the part of the Food and Drug Administration? It would seem so, given that the FDA has recently announced a new program that will double the amount of the user fees currently paid by the biggest players in the medical device industry. The new five-year medical device user fee deal, which is still awaiting Congressional approval, would seek $595 million from medical device manufacturers – a jump from the previous $287 million called for by the last five-year agreement. Another key component of the agreement is the requirement that the FDA meet with device companies through the process to address concerns and set goals for reducing review times. Continue reading →

← Older Entries