Hyman, Phelps & McNamara, P.C. Director Jeffrey N. Gibbs is a featured speaker at the Food and Drug Law Institute’s upcoming Medical Device Regulation and Litigation Conference. The conference is schedule to take place on July 18, 2012 at The Madison Hotel in Washington, DC. A …
By John R. Fleder – It is often said that a grand jury would indict a ham sandwich if asked to do so by a prosecutor. Some lawyers also say that the government cannot lose an FDA misdemeanor prosecution against current and former company officials because …
Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro is the featured presenter in a 90-minute webinar hosted by Elsevier Business Intelligence, titled “Discover the Impact of the FDA’s Eagerly Awaited Final Risk-Benefit Guidance.” The webinar is scheduled for June 19, 2012 at 1:00 PM …
By Kurt R. Karst – After a round of congratulatory speeches, the U.S. House of Representatives passed H.R. 5651, the FDA Reform Act of 2012, as amended, on May 30th by a vote of 387-5. Unlike the U.S. Senate, which passed its version of the bill …
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
By Jennifer D. Newberger – On May 7, 2012, Representative Lois Capps introduced the “Sentinel Assurance for Effective Devices Act of 2012” (H.R. 5341), many elements of which were also included in the House of Representatives Energy and Commerce Health Subcommittee user fee bill (see here). …
By Alan M. Kirschenbaum – On May 3, 2012, CMS posted on its website a notice announcing that manufacturers will not be required to collect data under the physician payment sunshine provisions of the Patient Protection and Affordable Care Act before January 1, 2013. As we have …
By Jennifer D. Newberger – On Tuesday, April 17, 2012, Senators Burr and Coburn introduced the Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at FDA Act, or the “PATIENTS’ FDA Act.” This bill is intended to complement the proposed user fee agreements negotiated between FDA and …
By Carmelina G. Allis – In a report released last week, the U.S. Government Accountability Office (“GAO”) provides the results from a study it conducted to determine whether FDA has met timeframe performance goals related to the completion of reviews for premarket notification (510(k)) submissions and …
By Jennifer D. Newberger – On March 27, 2012, FDA announced the release of a final guidance document, “Factors to Consider When Making Benefit-Risk Determination in Medical Device Premarket Approval and De Novo Classifications.” (A copy of FDA's March 28, 2012 Federal Register notice announcing the …
By Carmelina G. Allis – Amid recent reports alleging safety and effectiveness issues with a number of implant devices, a bipartisan group of Senators have introduced a bill entitled the “Ensuring Safe Medical Devices for Patients” (S. 2193). This bill is intended to strengthen FDA’s postmarket surveillance …
By Jennifer D. Newberger – On March 20, 2012, FDA published a notice in the Federal Register announcing a public meeting to discuss proposed recommendations (here and here) for the reauthorization of the Medical Device User Fee Act (“MDUFA”) for fiscal years 2013 through 2017. 77 …
By Jeffrey K. Shapiro – We previously discussed the government’s brief in the Par case in the context of what it says about FDA’s draft Research Use Only guidance. However, the government’s brief in Par is worth examining from another angle. (Note: the Par case involves …
By Jennifer D. Newberger – In September 2009, FDA engaged IOM, a member of the National Academy of Sciences ("the Academy"), to review the 510(k) medical device premarket review process and answer the following questions: (1) Does the current 510(k) clearance process protect patients optimally and promote …
By Jamie K. Wolszon & Jeffrey N. Gibbs – On February 15, 2012, Hyman, Phelps & McNamara, P.C. (“HPM”) submitted supplemental comments to FDA’s June 1, 2011 draft guidance (see our previous post here) that would limit the sale and distribution of Research Use Only (“RUO”) products. HPM’s …
