Resources

The high layoff numbers in the pharmaceutical industry and poor job prospects in a weak economy have flooded the market with would-be consultants to pharma companies that need extra help. Here are my suggestions for hiring and working with a good GMP consultant. 1. Define the scope of work before you start scouting for a […]

Congress is to be congratulated on its progress toward passage of user fee reauthorization legislation. House and Senate-passed versions are being reconciled by staff, with a few fairly tough issues yet to be resolved. There is no apparent barrier to a final piece of legislation later this month or during July. One of the big […]

The U.S. Supreme Court will rule on the constitutionality of the Affordable Care Act (ACA) (also known as ObamaCare) no later than early July. One of the possible results is nullification of the entire Act, althoughFDA Mattersthinks this is the least likely outcome. Nonetheless, the U.S. biosimilars law—passed as a separate section of ACA—could be […]

In honor ofFDA 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. Both are a fact of everyday life at FDA and in the […]

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 […]

OMB, White House staff, and the Secretary of HHS review many FDA decisions and their oversight sometimes alters FDA’s positions. This waschronicledin 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) […]

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 toconsider alternative pathways […]

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 […]

An important part of the 2012user fee reauthorizationcycle 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. Since these proposals have a common purpose, it is easy to think of them […]

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). Advocacy by the Alliance […]