A coalition in late March sent a letter to FDA commissioner Andrew von Eschenbach supporting a mandatory unique device identification (UDI) system and asking him to set a timeline to implement one. Under such a system, device manufacturers would be required to put a bar code or some other identifier on each of their devices to better enable safety-related tracking.
The Advancing Patient Safety Coalition is a broad-based organization comprising hospital, physician, nursing, research, quality, and patient advocacy organizations. (See the Sidebar on this page for member companies.) In its letter, the coalition stated that UDI is “a crucial factor to improving patient safety, reducing medical errors, facilitating device recalls, improving device adverse event reporting, and improving postmarket surveillance efforts.â€
The letter reminded von Eschenbach that the Food and Drug Amendments Act of 2007 contains language requiring FDA to set up a UDI system and urged the agency to write regulations for it as quickly as possible.
The device industry has had reservations about UDI because of the difficulty of trying to come up with a system that makes sense for each of the vast array of devices on the market.
“A national UDI standard has great potential for our entire healthcare system,†the coalition wrote. “It will improve patient safety while increasing efficiency for manufacturers by reducing the potential for counterfeit products being used on a patient. A UDI standard would also help contribute to the success of [electronic health records] and improve patient care by providing appropriate healthcare providers with accurate information.â€
– Erik Swain
FDA has issued a guidance for industry and FDA staff titled Expedited Review of Premarket Submissions for Devices. Its purposes are to develop a common understanding of when it is best to grant expedited reviews and to outline standard procedures to be followed to achieve an efficient expedited review process. The guidance has been updated from its 2003 version to reflect changes from last year’s FDA Amendments Act and corresponding changes in FDA’s expedited review policy for premarket approval (PMA) applications, premarket reports, product development protocols, and 510(k)s.
Under this revision, FDA will no longer require additional conditions so that an expedited PMA can be measured against Medical Device User Fee and Modernization Act expedited performance goals. As a result, the guidance no longer includes information specific to those additional conditions. Also, if a PMA or 510(k) is granted expedited status, such status would not be revoked during its review should a device of the same type be approved or cleared.
The document addresses topics such as devices appropriate for expedited review, the meaning and effect of expedited review, and how to request expedited reviews. To view the guidance, visit its Web page.
– James G. Dickinson
FDA today unveiled the Sentinel System, a series of databases that will allow it to query a broad array of information to identify possible post-market adverse events. Rather than waiting for adverse-event reports to trickle in, the agency will now be able to proactively search databases and look for problematic patterns of side effects and adverse events. If the system works as envisioned, the agency would be able to identify problems and alert doctors and patients to them much more quickly than it can now. This could prevent adverse events and save costs.
No patient-specific data will be returned in the searches, so privacy issues should not be a concern.
The effort will begin with a pilot program, using CMS’s Medicare Part D database. Eventually, FDA will also be able to search other CMS databases, and databases from the private sector — such as electronic medical records in hospital systems, and insurance-company databases.
The agency has prepared a white paper explaining how the system will work.
From MD&DI’s blog.
AdvaMed said it supports the changes recently made to a Senate bill on disclosure to patients of doctors’ financial ties to drug and device companies. “This bill is an important step forward in improving transparency and does so in a manner that does not jeopardize future innovation. That’s good news for patients, physicians and industry,” said Stephen J. Ubl, president and CEO of AdvaMed.
The modifications include preemption of state disclosure laws to ensure consistency; requiring compliance by physician-owned manufacturers, distributors, and group purchasing organizations; and requiring disclosure information to be displayed in an easy-to-understand manner. AdvaMed would like to see one more change: exempting companies who pay less than $250,000 per year to physicians.
– From MD&DI’s blog.
In testimony to the House Energy and Commerce Subcommittee on the first draft of the FDA Globalization Act, AdvaMed President Stephen J. Ubl said that funding for the foreign-inspection provisions of the act should come from appropriations, not user fees as proposed. He said funding via user fees could have unintended consequences, such as small device firms with no overseas operations unwittingly funding inspections for larger competitors that do operate overseas.
Instead, he said, Congress should create “a targeted funding mechanism for inspections of foreign facilities that are located in countries with less developed regulatory systems and actually export products to the U.S.”
He also asked Congress to reconsider a provision in the legislation that would require FDA to conduct pre-approval inspections of all Class II devices. Currently, pre-approval inspections are only required for Class III/PMA devices. More than 3600 Class II devices are cleared each year, and the requirement would bring the FDA approval process to “a screeching halt,” he said. Instead, he said, Congress should give more time for the third-party-inspection reforms included in the FDA Amendments Act of 2007 to work, and should leave FDA’s risk-based inspection policy alone.
The Medical Imaging Technology Alliance also weighed in. Elisabeth George of Phillips, a member of MITA’s board, said that FDA should leverage ISO 13485 inspections of overseas operations rather than conduct new inspections. She said 13485 inspections are “virtually identical” to FDA’s QSR inspection. She added that many of the bill’s provisions are duplicative and burdensome.
FDA Commissioner Andrew von Eschenbach has written to Congress that the agency needs an immediate infusion of $275 million, reports the New York Times. In a letter to Sen. Arlen Specter (R-PA), von Eschenbach itemized what the money is needed for, including opening foreign offices, increasing inspections of food, drug, and device plants, and adding databases.
This deviates from President Bush’s spending plan — it is rare than an FDA commissioner will make a request that so sharply differs from administration policy. But with all the criticism being levied at the agency from members of Congress in both parties, and with Bush’s lame-duck status, it shouldn’t come as too much of a surprise.
The $275 million is the same amount by which Sen. Herb Kohl (D-WI) amended an emergency appropriations bill in order to boost FDA’s budget. And the breakdown of how the money would be spent is similar in both plans. It is believed that Kohl based his proposal on von Eschenbach’s letter.
UPDATE: The Senate passed the emergency appropriations bill on May 15 and left Kohl’s amendment intact.
UPDATE 2: On June 9, the Bush Administration formally added $275 million to its budget request for FDA.
FDA Commissioner Andrew von Eschenbach admitted to Congress that the dispute over TMJ Implants’ appeal of a warning letter was “a process failure,” and said the agency is currently reviewing its procedures for handling disputes and appeals of warning letters, HealthImaging.com reports. An assistant commissioner is leading the review. The commissioner said FDA staff will follow up with the House Oversight and Investigations Subcommittee staff when the new procedures are in place.
Reps. Dan Barton (R-TX) and John Shimkus (R-IL) sent an angry letter to von Eschenbach last month over the treatment of TMJ Implants. CDRH issued a warning letter to the firm for not filing 17 Medical Device Reports, but the company disputed that MDRs were warranted. The firm says its appeal was never substantively reviewed before an FDA administrative law judge ruled against it and ordered it to pay $630,000 in fines.
– From MD&DI’s blog.
Sen. Herb Kohl (D-WI) has amended an emergency supplemental appropriations bill to add $275 million in funding for FDA, WisPolitics.com reports. Kohl, chairman of the Chairman of the Senate appropriations subcommittee that has jurisdiction over FDA, said he has “serious concerns” about the agency’s ability to do its job with present funding. Of the total funding in the bill, $125 million is for food safety activities; $100 million is for medical product and drug safety activities; $40 million is for modernizing FDA science and the FDA workforce; and $10 million is to upgrade FDA facilities and laboratories outside of Washington, DC.
The Alliance for a Stronger FDA welcomed the news. “By placing additional funding in this year’s emergency supplemental bill, Senator Kohl has highlighted the size and urgency of FDA’s needs,” said association President Wayne Pines.
UPDATE: The Senate passed the bill on May 15 and left Kohl’s amendment intact. A similar measure is now needed in the House.
FDA said yesterday that it wants to fill more than 600 new positions and more than 700 vacant ones by October, triple the number of people it hired between 2005 and 2007. This comes in response to rampant criticism of lax oversight and lack of specialists who are able to keep up with the latest technological advances. Hires will include biologists, chemists, medical officers, statisticians, epidemologists, and others, reports the Associated Press. About 150 will be inspectors, as the agency’s understaffed inspection team has come under fire recently.
This is just the beginning. 30% of FDA staff is eligible to retire, as is almost half of FDA management. Word on the street has been that many will choose to retire rather than move to the agency’s new White Oak facility when that is finally ready to be fully operational.
The agency will be holding job fairs around the country and has received permission from the Office of Personnel Management to expedite the hiring process.
– From MD&DI’s blog.
