Dear Sir or Madam:
The Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) are pleased to submit these comments in response to the Food and Drug Administration’s (FDA’s) Draft Prescription Drug User Fee Act V (PDUFA V) Information Technology Plan (IT Plan). PhRMA is a voluntary, non-profit association that represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested approximately $550 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012 alone. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
The PDUFA V Performance Goals (Section XIV. B.) commit the FDA to periodically updating and publishing a five-year plan for business process improvement enabled by IT investments. PhRMA and BIO remind the Agency that the last update to the PDUFA IV IT Plan was published on September 19, 2011 with information current as of May 2010. PhRMA and BIO note that the 2011 update of the IT plan indicates that the information is valid through September 2012. Therefore, there has been a period of 15 months during which FDA was unable to provide a current IT plan to the Industry and the public. With the publication of the proposed PDUFA V Goals Letter on September 1, 2011 and the reauthorization of PDUFA V on July 9, 2012, PhRMA and BIO expected that the Agency would be timelier in the publication of an IT plan that addressed the outstanding PDUFA IV IT initiatives and new PDUFA V IT initiatives (e.g., having a draft IT plan available for public review in the first quarter of PDUFA V). PhRMA and BIO note that the Agency published the draft plan over one year into PDUFA V and only shortly before the publication of draft guidance that, when final, will trigger new regulatory requirements for electronic submission and data standardization. Further, we believe that additional rounds of revision to draft guidance4 intended to implement PDUFA V goals may have been avoidable had a PDUFA V IT plan been in place earlier (e.g., at the start of PDUFA V). The delay in the release of this plan has a significant, negative impact on Industry’s ability to budget for, adequately plan for, and prioritize internal investments that are necessary to meet new regulatory requirements and expectations. PhRMA and BIO appreciate the effort put forth by the Agency to develop this draft plan; however, we urge the FDA to publish the PDUFA IT plans in a timelier manner and without gaps in time during which no current plan is available.