Resources

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 […]

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 […]

My blood boils when I read an article such as the one that appeared in the New York Times yesterday entitledSupply 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 […]