Proposed Legislation to Speed the Approval of Drugs

Ph03349i The current Congress has been a largely do-nothing body.  It has enacted less legislation than most.  They spent days last week debating gay marriage regarding an amendment everyone knew would fail while there were pressing matters demanding their attention.  They have, on the other hand, been extremely busy raising money for their re-elections.  Because of all the distraction, when to actually do something, it is easy to miss it.

But in May, 2006, Senator Richard Lugar (R-Ind) introduced legislation into the Senate – S. 2973 entitled the Pharmaceutical Technology and Education Enhancement Act (PTEEA) and it was referred to the Committee on Health, Education, Labor, and Pensions.  Senator Lugar is the only sponsor and there is no companion legislation introduced in the House of Representatives.  There is no sign that this is going anywhere.

However, the germ of the idea is intriguing.  The last time legislation was enacted that was, at least in part, geared to speeding up drug approvals was in the 1990’s when legislation made Fast Track, Accelerated Approval and a formula for shortening approval times available through the Food and Drug Administration Modernization Act (FDAMA) and the Prescription Drug Users Fee Act (PDUFA).  Those pieces of legislation had very specific proposals for reducing the time of approval for drugs.  PTEEA is more about process than event.

PTEEA calls for the Commissioner (when there is one) to expand efforts under research and education programs through the National Institute for Pharmaceutical Technology and Education (NIPTE) and to create a coordinating committee to consider strategies for the "rapid design, enhanced manufacturing process, and improved quality related to new medical technology development…"  The idea is to create a plan for speeding up the process, rather than offering a solution within the legislation.

That may provide some insight as to why the legislation has no co-sponsors.  It is not exactly exciting.  But the idea that approval times need to be abbreviated is most certainly a good one.  Emerging pathogens develop stealthily (HIV, e.g.) and can spread rapidly (West Nile Virus, e.g.,).  Industry is under a tremendous amount of pressure to quickly develop diagnostic tests, assays to determine exposure, and ultimately treatments and vaccines in short order.  If we want to be as stealth, government and industry have to work together to develop viable solutions to speeding the processes of approval, while still preserving safety.

By the way, if you are interested in tracking this or other pieces of legislation,  a wonderful resource exists with  It is free to sign up.

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