Will the Dog Days of Summer Offer a Reprieve to FDA and the Regulated Industry (and Your Bleary-Eyed Bloggers)? Doubtful

July 6, 2011

By Kurt R. Karst –    

Over the Independence Day holiday, in between the family BBQ and fireworks, we had a few minutes to reflect on what a hectic month June was for FDA and the regulated industry.  There were the decisions handed down by the U.S. Supreme Court in Mensing and Sorrell (here and here), and the Court’s decision to hear Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S (Docket No. 10-844).  June also saw a host of new lawsuits and appeals, including the ReGen and PREVOR Complaints filed against FDA.  The U.S. Government Accountability Office issued a bevy of reports on issues including antibiotic resistance, the influenza pandemic, medical device recalls, and a late May report on pediatric research

FDA, of course, had its hands full with the AVASTIN (bevacizumab) hearing, but the Agency still found time to issue myriad guidance documents, reports, rules and regulations, and other decisions on issues including Research Use Only and Investigational Use Only products, 505(q) citizen petitions, OTC sunscreen drug products, nanotechnology, and global product safety and quality.

Things were particularly busy on Capitol Hill where a flurry of bills were introduced in June, and several missives to FDA and the regulated industry were generated (see, e.g., here, here, here, and here).  Below is a sampling of the FDA-related bills recently introduced in Congress.

  • Dietary Supplement Labeling Act of 2011 (S. 1310)
  • Preservation of Antibiotics for Medical Treatment Act of 2011 (S. 1211)
  • Medicare Drug Savings Act of 2011 (S. 1206)
  • Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 (H.R. 2405)
  • Safe Cosmetics Act of 2011 (H.R. 2359)
  • America Rx Act of 2011 (H.R. 2296)
  • Preserving Access to Life-Saving Medications Act of 2011 (H.R. 2245)
  • Medical Gas Safety Act (H.R. 2227)
  • Skin Cancer Prevention, Education, and Consumer Right-To-Know Act (H.R. 2132)
  • Ryan Creedon Act of 2011 (H.R. 2119)

There are no signs of activity letting up for the rest of the year and into 2012.  Reauthorization of the Prescription Drug User Fee Act (“PDUFA”) – PDUFA V – will likely begin to take center stage.  The House Energy and Commerce Committee Health Subcommittee will hold a hearing on PDUFA on July 7th.  According to a hearing background memo, “[o]n September 1, 2011, FDA will publish the details of the agreement recommendations on its website.  A public meeting on the recommendations will follow in October 2011. By January 15, 2012, FDA must send its final recommendations to the Committee and the Senate HELP Committee as required by statute.”  As with previous iterations of PDUFA, PDUFA V will likely act as a vehicle to which other FDA-related measures are added, including perhaps generic drug user fees and biosimilars user fees.  As always, your intrepid bloggers will be there to report on these and other events.