CIMIT: January 2009 Regulatory Affairs Newsletter

January 2009 Regulatory Affairs NewsletterPrint this page

Obama Halts Pending Regulations
FDA Moves Forward with Unique Identifies for Devices
GAO Calls for Increased Oversight of Devices
FDA Issues Final Guidance on Clinical Trial Certification
Stimulus Bill Raises Concern in Device Industry
GAO Issues Report on the 510(k) Program
Obama Likely to Announce FDA Commissioner Soon
FDA Issues Guidance on Off-Label Information in Medical Materials
Website Could Track Effect of Reimbursement on Clinical Trials
FDA Needs More Resources, Stronger Leadership, Daschle Says
CDRH Staffers Send Letter to Obama Transition Team
CMS Lessens Data Burden for Cancer PET Coverage
AdvaMed Questions Role of New Electronic Event Reporting System
FDA Considering Adoption of ISO 13485
Clinical Trial Violation Rate Down in 2008, but Improved Monitoring Required

Obama Halts Pending Regulations.
President Obama has instructed all current federal departments and agencies not to issue regulations until his political appointees have signed off on them. Obama is seeking to prevent policies that were pushed through in the last days of the Bush administration from taking effect. Department of Health and Human Services (“HHS”) regulations, including a new ICD-9 coding system, could be affected. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Moves Forward with Unique Identifies for Devices.
FDA likely will have a proposed rule published by the end of 2009 that mandates use of unique identifiers for medical devices. The agency has scheduled a meeting for February 12, 2009, at which it expects to gather the final information needed to create a system for labeling individual devices with bar code-style identification. Additional information is available at www.thegraysheet.com (paid subscription service).

GAO Calls for Increased Oversight of Devices.
The Government Accountability Office (“GAO”) has issued its usual list of “high risk” government operations for the new Congress to consider, and has urged Congress to increase oversight of drugs, devices, and other medical products. GAO cited specific concerns with FDA’s oversight, including reported deficiencies in foreign inspections, postmarket monitoring, promotional materials, and clinical trial oversight. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Issues Final Guidance on Clinical Trial Certification.
On January 21, 2009, FDA issued final guidance outlining when device manufacturers must certify to the agency that clinical trials have been registered with ClinicalTrials.gov. Companies must submit a completed certification form along with any submission for a PMA, panel track supplement, or humanitarian device exemption (“HDE”). Additionally, 510(k) submissions that refer to, relate to, or include clinical trial data must also include a certification. Additional information is available at www.thegraysheet.com (paid subscription service).

Stimulus Bill Raises Concern in Device Industry.
As part of the economic stimulus bill currently in Congress, the House Appropriations Committee has approved $1.1 billion to fund studies comparing the effectiveness of health care treatments and strategies. The bill has raised the ire of the device industry, which wants to see a clear statement in the bill that comparisons of clinical effectiveness, rather than cost alone, will be the focus of the research. Additional information is available at www.thegraysheet.com (paid subscription service).

The Government Accountability Office (“GAO”) has issued a long-awaited report
on the premarket review process for medical devices.
Congress mandated in the FDA Amendments Act of 2007 that the GAO conduct the report, which was to evaluate whether devices are being cleared through the 510(k) process that should undergo the PMA process. The report is available at http://www.gao.gov/new.items/d09190.pdf. Additional information is available at www.thegraysheet.com (paid subscription service).

Obama Likely to Announce FDA Commissioner Soon.
President Obama’s search for a new FDA commissioner is over, according to sources close to the transition team. The final two candidates for the post are Dr. Joshua Sharfstein, head of the Baltimore City Health Department, and Dr. Robert Califf, a cardiologist at Duke University School of Medicine. The announcement of the new commissioner could come as early as this week, and Senate confirmation as early as March. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Issues Guidance on Off-Label Information in Medical Materials.
FDA has issued final guidance that allows companies to distribute journal articles containing information on off-label uses of a drug or device, provided certain requirements are met. The articles must come from peer-reviewed journals, be based on clinical data, and include a statement that the off-label uses have not been approved by FDA. Rep. Henry Waxman, D-Calif., is calling on the new administration to reconsider the guidance. Additional information is available at www.thegraysheet.com (paid subscription service).

Website Could Track Effect of Reimbursement on Clinical Trials.
The website ClinicalTrials.gov could be used to determine whether payment policies set by CMS and third parties have an impact on clinical trial participation, according to a draft report from the Agency for Healthcare Research and Quality (“AHRQ”). The report proposes requiring every trial to collect certain subject data, to help assess whether reimbursement policies incentivize or disincentivize certain patients and physicians to participate. Public comments on the report can be submitted through January 23, 2009 at http://www.ahrq.gov/clinic/ta/taform3.asp. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Needs More Resources, Stronger Leadership, Daschle Says.
HHS Secretary nominee Tom Daschle told the Senate Health, Education, Labor and Pensions Committee last week that FDA needs more resources, stronger leadership, and better public policy, to improve the drug and device approval process. Daschle said he plans to select new FDA leaders in the next few weeks and has already been interviewing candidates. The nominee also said that he would give FDA scientists “as much autonomy as they need,” to prevent ideology and politics from affecting drug and device approvals. Additional information is available at www.thegraysheet.com (paid subscription service).

CDRH Staffers Send Letter to Obama Transition Team.
CDRH scientist and physicians sent a letter last week to John Podesta, head of President-Elect Barack Obama’s transition team, claiming that Office of Device Evaluation (“ODE”) managers have coerced and intimidated scientists at FDA into modifying scientific evaluations. The letter urged the new administration to seek resignations from all current ODE managers and dismantle ODE into multiple offices headed by rotating leaders. Additional information is available at www.thegraysheet.com (paid subscription service).

CMS Lessens Data Burden for Cancer PET Coverage.
In a draft national coverage determination release last week, CMS proposed removing some coverage-with-evidence-development (“CED”) requirements for PET scans for various cancers. CMS suggests retaining data collection requirements for PET scans that will evaluate the effect of treatment or a patient’s suitability for different treatment. Comments on the proposal are due Feb. 5, 2009 and can be made at https://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?from2=viewtrackingsheet.asp&id=218&.
Additional information is available at www.thegraysheet.com (paid subscription service).

AdvaMed Questions Role of New Electronic Event Reporting System.
AdvaMed has submitted comments to FDA in response to a Federal Register notice seeking feedback on the Agency’s new electronic MedWatch Plus adverse event reporting system. The group asked FDA to clarify whether the Med Watch Plus system will replace or incorporate the electronic Medical Device Reporting (eMDR) system currently used by many device firms to electronically report adverse events. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Considering Adoption of ISO 13485.
FDA may incorporate ISO 13485 into the Quality System Regulation (QSR) or, alternatively, the Agency may eliminate the QSR entirely and replace it with ISO 13485, FDA quality systems experts say. The Agency would only adopt ISO 13485, however, if the international standard’s requirements for process validation and software validation were revised. Currently, ISO 13485 does not include a process validation requirement, and the standard only requires validation of software used for manufacturing. Additional information is available at www.thegraysheet.com (paid subscription service).

Clinical Trial Violation Rate Down in 2008, but Improved Monitoring Required.
In 2008, only 22% of device firms inspected by CDRH’s bioresearch monitoring division potentially violated clinical trial regulations, down from 33% in 2007. Though clinical trial compliance improved over 2007, the 2008 violation rate was still double the 2006 violation rate of 11%. Failure to properly monitor clinical trials remains the number one problem among device firms, and the fluctuating violation rates appear to be driven by complaint-based inspections, according to CDRH. FDA is currently working on a Clinical Trials Transformation Initiative, which will research alternative approaches to clinical trial monitoring in an effort to aid industry. Additional information is available at www.thegraysheet.com (paid subscription service).