FDA Commissions IOM Review of 510(k) Program.  FDA has commissioned the Institute of Medicine (“IOM”) to investigate whether the agency’s 510(k) premarket notification program promotes innovation while still protecting patients.  The announcement follows months of criticism of the 510(k) process by agency whistleblowers and members of Congress, who recently proposed requiring an IOM review of the program.  The agency will pay $1.3 million for the IOM study, which will also make recommendations as to whether legislative or regulatory changes should be made to the 510(k) program.  

Health Reform Bills Address Physician Payments.  As Congress tries to rectify health reform bills approved by various House and Senate committees, debate has ensued over provisions that would require drug and device companies to publicly disclose payments to physicians.  So far, three House bills and one Senate bill have all included such “physician payment sunshine” provisions.  The device industry has been generally supportive of such provisions, provided that they preempt state rules on the topic, preventing a state-by-state patchwork of disclosure rules.  

FDA Issues Good Manufacturing Practices for Combination Products.  FDA has published a long-awaited proposed rule regarding good manufacturing practices for combination products.  The rule attempts to streamline the quality control requirements for combination products, which are technically subject to all the necessary parts of device, drug, and biologic manufacturing regulations, depending on the product.  The proposed rule would allow makers of combination   products to take a streamlined approach to ensuring quality in manufacturing, that accounts for duplicative provisions of the various quality regulations. 

New Combination Product Rules Expected Soon.  In the coming weeks, FDA plans to publish two long-awaited proposed rules in the Federal Register, which address current good manufacturing practices (“cGMP”) and adverse event reporting for combination products.  Industry has requested for years that FDA issue guidance on these two topics, particularly to aid companies in organizing their manufacturing systems.  FDA staff say that the manufacturing rule generally will require companies to adopt either a quality system per the device regulations or a cGMP system per the drug regulations, with companies augmenting the system with additional procedures specific to the type of combination product.

New Guidance Issued for AFib Device Trials.  On September 14, 2009, FDA issued draft guidance that allows companies to use non-randomized trials to support marketing approval applications for atrial fibrillation devices.  The guidance notes the agency’s preference for randomized, controlled trials but also recognizes the difficulties companies have had designing such trials for these devices, particularly due to the selection of the control.  Thus, FDA states that companies could use nonrandomized concurrently controlled studies or historical controls, where necessary.  The guidance does not apply to catheter ablation devices, however, which have been addressed in previous guidance documents. 

FDA to Hold Public Meeting on Internet Advertising.  After repeated requests from industry, FDA has announced it will hold a public hearing on November 12-13, 2009 regarding Web-based advertisements for drugs, devices, and biologics.  Currently, no specific guidance exists on the use of Internet-based media for advertising and promotion, with FDA merely treating Web-based advertisements as traditional print and broadcast promotions in the most recently issued advertising guidance.  Attendees must register for the meeting by October 9, 2009, but FDA will accept written comments on the issue through February 28, 2010.  

Health Reform Bill May Charge Device Industry $4 Billion.  The Senate Finance Committee will consider a health care reform bill this week that could cost the medical device industry $4 billion annually.  Committee Chair Sen. Max Baucus (D-Mont.) made public the details of his health reform framework last week, which helps fund health care reform via a fee on the medical device industry.  Each company would be charged a fee annually, beginning in 2010, and the amount of the fee would be determined by a company’s market share.  Device industry trade groups oppose the fee and contend that it will tax innovation and outweigh any benefit to the industry from current health reform proposals. 

Industry Lauds Harkin’s Takeover of Committee.  Sen. Tom Harkin (D-Iowa) has been appointed to succeed Sen. Edward M. Kennedy (D-Mass.) as the chairman of the Senate Health, Education, Labor and Pensions Committee.  Medical device industry trade groups praised the appointment, noting that Harkin is a strong supporter of disease prevention, particularly health screening, a position shared by the device industry.  Harkin has led the charge, however, to reverse a Supreme Court decision protecting device companies from state liability lawsuits, holding a hearing on the issue as recently as August. 

Use of Registries Could Ease Post-Approval Study Burden.  FDA is encouraging medical device companies to use data from ongoing device registries to fulfill post-approval study requirements.  At a recent public workshop on post-approval studies, the agency noted that use of such existing data would ease the burden on both device companies and health professionals participating in the studies.  Importantly, it would also aid companies in completing such studies, which often do not progress according to agency expectations.  FDA staff members noted at the meeting that using registry data would prevent companies from having to start from scratch with post-approval studies.