A Medical Device Daily
The House of Representatives managed to get its version of the FDA reauthorization bill (H.R. 2900) onto the floor for a vote Wednesday night, but it promises to clash with the Senate's bill (S. 1082), passed earlier this year.
The House version sailed through on a vote of 403-16 after a number of proposed measures were floated in the House Energy and Commerce Committee's health subcommittee (Medical Device Daily, June 27) to the objection of both FDA and the GOP.
Randall Lutter, PhD, FDA's associate commissioner for policy and planning, said at the June 12 hearing that while FDA supported reauthorization of the Best Pharmaceuticals for Children Act (BCPA) and the Pediatric Research Equity Act (PREA), an internal review requirement included in the Democrats' proposal "will make these successful programs virtually unworkable," due in part to a reduction of the exclusivity provision for existing approved drugs products from six months to three. This, Lutter said, would drain the incentive to conduct the necessary trials.
However, the final version gives exclusivity for six months.
A proposal to boost the third-party inspection program, sponsored by Jay Inslee (D-Washington) and Joe Pitts (R-Pennsylvania), received a less than glowing reception by the majority Democrats but nonetheless managed to survive into H.R. 2900.
The House bill directs FDA to refund 75% of fees paid for modular applications so long as the application is withdrawn before the second module is submitted and before FDA acts on the initial module.
The bill also calls for additional $7.1 million to be appropriated to the agency's budget in FY08 for post-market review of medical devices, with a similar amount in the two following years after adjustment for inflation.
One of the pressures on the two houses of Congress to reconcile their respective bills is that the agency will run out of money and would have to start issuing reduction-in-force notices to employees if the task is not accomplished before Congress leaves town for the August recess.
Some members of the Senate are interested in passing S. 1695, the Biologics Price Competition and Innovation Act of 2007, that would create a standard of "interchangeability" for follow-on biologics. According to the web site Govtrack.us., this bill has yet to make it out of the Senate Health, Education, Labor and Pensions Committee, and there is even less momentum in the House toward a similar measure.
Frank Pallone (D-New Jersey), chair of the Energy and Commerce health subcommittee, was quoted by Congressional Quarterly as saying that "there is no consensus" on the matter in his committee.
News of the House action drew praise from industry, with the Medical Imaging & Technology Alliance (MITA; Arlington, Virginia) issuing a statement that "applauded" the House reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA).
Andrew Whitman, the association's president, said in a statement that the reauthorization "helps ensure that the medical imaging technologies so critical to healthcare today will be accessible to patients and providers in a timely, safe and effective manner."
Whitman also said the association "is particularly grateful to representatives Joe Pitts (R-PA) and Jay Inslee (D-WA), whose third-party amendments will help FDA have the resources it needs to keep up with the rapid pace of medical device innovation," Whitman said.
And Stephen Ubl, president of the Advanced Medical Technology Association (AdvaMed; Washington), said in a statement that H.R. 2900 "will enhance patient safety by providing FDA's device program with the financial resources it needs to meet its medical technology review commitments while protecting future FDA appropriations and providing manufacturers with predictability regarding user fee rates." Ubl urged Congress "to quickly name members to a conference committee so that differences between the two chambers' versions of the legislation can be reconciled and a final bill sent to the President before the current user fee program expires on September 30."
NIH launches Pipeline to Partnership site
Fans of acronyms and healthcare policy will surely respond with enthusiasm to the report by the National Institutes of Health (NIH) that it has launched a web-based means of accelerating the co-licensure of its research products called NIH Pipeline to Partnership, or P2P (acronym cum numeral, no less).
The P2P initiative will boost the sharing of licensed technologies with industry via the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. According to the NIH announcement, the portal "provides a virtual space where NIH licensees and NIH SBIR/STTR awardees can showcase their technologies and product development for an audience of potential strategic partners, investors, and licensees."
Mark Rohrbaugh, PhD, director of the NIH Technology Transfer Office, said in a statement that over the past decade, "many successful biomedical products have come from pharmaceutical and biotechnology companies that licensed early-stage technologies from NIH."
The site — www.ott.nih.gov/P2P — lists licensing opportunities by application and disease categories. Among the application categories are diagnostics, therapeutic interventions, and devices. The diagnostic licensing category lists 15 opportunities whereas the devices and instrumentation category lists 17. The companies that are listed typically are seeking a partnership to bring their products to market.
Jo Anne Goodnight, coordinator of the SBIR/STTR programs said that the firms that list at the site "simply can't go it alone …. We see the P2P database as an important resource to help small businesses make a successful leap from discovery to commercialization of products resulting from innovative biomedical and behavioral research."