Author Archives: StevenGrossman

Biosimilars and the U.S. Supreme Court: FDA Program Could Be Nullified

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, although FDA Matters thinks this is the least likely outcome. Continue reading

Safety and Efficacy Standards: Innovative Approaches to Radical Ideas

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?

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

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

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”

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

Biological Complexity and the Myth of the Low-Hanging Fruit

Two events persuaded FDA Matters to write another column on biological complexity and its implications for medical research, drug discovery, and personalized medicine. First was the release of a remarkable study on gene mutations in cancer tumors. It is a stellar and sobering example of how biological complexity confounds our expectations that rapid advances in science will quickly lead to cures.  Continue reading

Why is Drug Discovery So Hard (and Expensive)?

Notwithstanding herbal medicines and the re-emergence of leeches as therapy, it is only in the last 70 years that physicians have had proven medical science to support “the healing arts.” Potions and procedures of dubious value have been replaced by powerful medicines that treat infections, heart disease, diabetes and mental illness. Continue reading