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March 2009 Regulatory Affairs Newsletter
IRBs Standards Raised at Congressional Hearing.
Institutional Review Boards (“IRBs”) and HHS were chastised for shortcomings in IRB oversight, at a March 26, 2009, hearing of the House Subcommittee on Oversight and Investigations. After an undercover investigation revealed that HHS registered a fraudulent IRB and an IRB approved a fake clinical trial protocol, lawmakers noted that legislation to prevent IRB shopping may be necessary. One legislator already has proposed a law that would set standards for IRBs and expand the number of clinical trials subject to federal regulation. FDA staff at the hearing defended the agency’s oversight of clinical trials, noting that the sponsor of the sham product would have had to submit an investigational device exemption (“IDE”) application before the trial would have been allowed to proceed, at which point the falsity would have been discovered. Additional information is available at www.thegraysheet.com (paid subscription service).
Electronic Medical Records as Medical Devices?
Since President Obama included $19 billion in his stimulus plan for promoting electronic medical records (“EMRs”), some advocates have called for increased regulation of EMRs. In response, FDA created an EMR and health information technology working group to investigate whether EMRs meet the definition of a medical device, such that FDA would regulate the systems or software associated with EMRs. Currently, EMRs need only be certified by the Certification Commission for Health Information Technology prior to marketing. The EMR industry opposes FDA regulation of EMRs, noting that it will hinder widespread adoption of the technology. Additional information is available at www.thegraysheet.com (paid subscription service).
FDA/Sponsors Investigate Preclinical Testing for Heart Valves.
FDA and industry are working to create computer models that would simulate stresses placed on percutaneous replacement heart valves, in an effort to identify preclinical testing standards for the devices. Given the role and positioning of the valves in the body, developing adequate preclinical testing for this emerging technology is a challenge. While FDA would like to see six to nine months of testing, representing about 15 years in the life of an implanted valve, industry believes a shorter testing period is adequate. FDA also is augmenting its domestic efforts by working with an international working group to amend the International Standards Organization cardiac valve standard to address percutaneous valves. Additional information is available at www.thegraysheet.com (paid subscription service).
Industry, FDA Staff Optimistic About New Leadership.
The nominations of Dr. Margaret Hamburg and Dr. Joshua Sharfstein to head FDA has prompted a cautious, but optimistic response from both FDA staff and the device industry. FDA does not expect widespread resignations in response to the nominations, as sometimes occurs with political appointments. However, some agency staff are concerned that Hamburg may try to micromanage device reviews and that Sharfstein is too close to former employer Rep. Henry Waxman (D-Calif.). Industry appears to have a similar response to the appointees. Additional information is available at www.thegraysheet.com (paid subscription service).
FDA Memo Urges Confidentiality.
Acting FDA Commissioner Frank Torti issued a memo to FDA staff March 13, 2009, stating that agency employees must comply with legal requirements to maintain confidentiality of certain information. While the agency supports transparency, Torti noted that FDA staff are required by law to keep confidential any information they learn pertaining to trade secrets, confidential commercial information, personal privacy data, law enforcement records, and privileged inter- and intra-agency documents (including internal e-mails). The memo comes on the heels of whistleblower allegations alleging improper coercion in device reviews at FDA, and the potential release of confidential information by the whistleblowers. Additional information is available at www.thegraysheet.com (paid subscription service).
Chief Counsel Review of QSR Warning Letters May Cease.
The Office of the Chief Counsel (“OCC”) at FDA may reduce the number of FDA warning letters it reviews, or cease reviewing them altogether. Currently OCC reviews every domestic warning letter that addresses quality system violations, to ensure that the letters are supported by the FDA inspection that identified the violation. However, OCC only reviews one out of five warning letters aimed at foreign device companies, so FDA may consider similarly limiting review of domestic letters. FDA staff note, however, that modifications would depend on whether regional arms of the agency demonstrate that they can produce accurate warning letters. Additional information is available at www.thegraysheet.com (paid subscription service).
Obama Appoints Hamburg FDA Commissioner.
This weekend, President Obama named former New York City Health Commissioner Dr. Margaret A. Hamburg as his new FDA Commissioner. In his weekly address to the nation, Obama also announced his appointment of Baltimore Health Commissioner Dr. Joshua Sharfstein to serve as Hamburg’s deputy. Hamburg is an expert in public health and biological/microbial threats, who previously worked in the Clinton administration. Sharfstein previously worked with Rep. Henry Waxman (D-Ca.), the current chairman of the Senate Committee on Oversight and Public Reform. Congressional representatives praised Obama’s choice to look outside FDA for new leadership, saying low morale and funding have rendered the agency too lenient on industry and unable to effectively regulate drugs, medical devices, and food. Additional information is available at washingtonpost.com and reuters.com.
Reviewers Continue to Clash with FDA Supervisors over 510(k)s.
In the months since eight scientists from the Center for Devices and Radiological Health (“CDRH”) sent letters to members of Congress and the Obama transition team alleging inappropriate coercion in review of 510(k) submissions, CDRH reviewers and supervisors continue to clash, according to reports. Reviewers allegedly are examining 510(k) submissions more carefully and asking for undue amounts of information to support substantial equivalence findings, leading supervisors to postulate that some reviewers are not adequately trained in federal device regulations. Meanwhile, reviewers maintain that supervisors have inappropriately cleared devices without proper scientific information, via the 510(k) pathway. Additional information is available at www.thegraysheet.com (paid subscription service).
CDRH Issues Guidance Regarding PMA Fees.
FDA has issued draft guidance outlining when PMA user fees are required, which PMAs are exempt from user fees, and how and when FDA will refund PMA user fees. The guidance notes that FDA will refund portions of the user fee for traditional PMAs or panel-track supplements if FDA issues a non-filing letter or the applicant requests withdrawal of the submission, provided FDA has not taken a first action in reviewing the submission. The guidance also addresses PMA user fee refunds for modular PMAs, PMA supplements, and 30-day notices, among other things. Additional information is available at http://www.fda.gov/cdrh/ode/guidance/1681.html#4.
AdvaMed Releases Guidelines for DTC Ads.
On March 5, 2009, AdvaMed released a set of 13 principles for device industry firms to live by when creating direct-to-consumer (“DTC”) advertising campaigns. AdvaMed suggests that ads clearly disclose risks and that companies send videos of new television ads for restricted devices to FDA, prior to airing the ads. The principles come after Sen. Herb Kohl, chairman of the Special Committee on Aging, indicated that he would allow the device industry to first police itself before he would initiate legislation to regulate device DTC campaigns. Additional information is available at www.thegraysheet.com (paid subscription service).
Device Industry Not Likely to be Hard-Hit by Obama Budget.
Though stock in medical device firms fell at a faster rate than the rest of the market after the announcement of President Obama’s new budget, industry analysts say the plan presents little risk for the device industry. The budget includes some provisions tangentially related to the device sector, but very little in the plan directly impacts the device industry. Analysts claim the tumbling stocks are due to overreacting investors and that even provisions such as a preauthorization requirement for imaging scans and proposed hospital cuts will not severely affect device firms. Additional information is available at www.thegraysheet.com (paid subscription service).
FDA, NIH to Address Pediatric Devices.
In response to the FDA Amendments Act of 2007 (“FDAAA”), FDA and NIH will soon be releasing reports to Congress outlining long-term plans for incentivizing pediatric device development. NIH intends to focus on the potential commercialization plan when reviewing grants for pediatric device research. Additionally, NIH is hosting a series of workshops on developing pediatric devices, with the next such workshop planned for April 23, 2009. FDA, on the other hand, will require that device firms include pediatric data in premarket submissions for medical devices. Additional information is available at www.thegraysheet.com (paid subscription service).
FDA Increasing its Focus on Science.
Acting FDA Commissioner Frank Torti has outlined new scientific projects and initiatives to be undertaken by the agency, in an effort to improve FDA’s reputation and its scientific rigor. The report outlines seven scientific priority areas that the agency should focus on to improve product regulation. Within each priority area, FDA centers have agreed to undertake specific projects to address that priority area. CDRH has four projects planned that would address the safety of ophthalmic devices, chemical contamination of device surfaces, endpoints for cardiovascular device evaluations, and clinical trial design for imaging devices. Additional information is available at www.thegraysheet.com (paid subscription service).
Budget Proposes Pre-authorization for Imaging Services.
President Obama’s proposed budget for fiscal year 2010 would require imaging services ordered by a physician to be preapproved by a radiology benefit manager (“RBM”) in order to be reimbursed under Medicare. Imaging device firms and radiologists strongly oppose the measure, saying it allows RBMs to interfere in medical decision-making. Additionally, while RBMs would use criteria formulated from practice guidelines to make their decisions, critics contend that RBM decisions are rarely public, rendering it hard to assess each decision. The Obama administration hopes to save $260 million by using this approach, most of which is intended to help pay for large scale health care reform. Additional information is available at www.thegraysheet.com (paid subscription service).
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