CIMIT: February 2009 Regulatory Affairs Newsletter

February 2009 Regulatory Affairs NewsletterPrint this page

Comparative Effectiveness Research Made Into Law
Industry Awaits Combination Products Regulations and Guidance
Sponsors Requesting Add-On Payments Look for FDA Approvals
Comparative Effectiveness Research Bill Passes
Sunshine Act Revised to Prevent Duplication
FDA to Require More Oversight of Suppliers
FDA Unique Identifiers Should Address Risky Products First
Administration Official Weighs in on Cost-Effectiveness Research
Daschle’s Withdrawal May Have Far-Reaching Effects
HHS Guidance Leaves Questions Unanswered
FDA Device Staff Refute Whistleblowers’ Claims
Device Industry Hopes for Senate Version of Stimulus Bill
Globalization Act Addresses Oversight of Foreign Device Manufacturers

Comparative Effectiveness Research Made Into Law.
On February 17, 2009, President Obama signed into law a stimulus package, entitled the American Recovery and Reinvestment Act, including the provision calling for $1.1 billion in comparative effectiveness research. The law institutes a federal coordinating council to oversee the comparative effectiveness studies and requires Health and Human Services (HHS), the Agency for Healthcare Research and Quality (AHRQ), and the National Institutes of Health (NIH) to provide an operating plan to congressional appropriators prior to any of the money being dispersed. Additional information is available at www.thegraysheet.com (paid subscription service).

Industry Awaits Combination Products Regulations and Guidance.
After four years, FDA’s Office of Combination Products (OCP) still has not issued proposed rules on good manufacturing practices and adverse event reporting on combination products, much to industry’s chagrin. The rules are finished and undergoing review by high-level OCP officials, but President Obama’s freeze on the issuing of regulations by all federal agencies has further delayed the long-awaited rules. Firms also are anxiously awaiting draft technical guidance on auto-injectors, which OCP says will be released within the next six months. Additional information is available at www.thegraysheet.com (paid subscription service).

Sponsors Requesting Add-On Payments Look for FDA Approvals.
Many device manufacturers that applied for new technology add-on payments through Medicare in November are still waiting for FDA approval decisions for their devices. Firms must receive clearance or approval of their devices by July 1, 2009, in order to be eligible for 2010 add-on payments, which are allowed for products that have been marketed for three years or less and represent substantial improvement over other treatment modalities, but would not receive adequate reimbursement under Medicare’s current inpatient payment system. Additional information is available at www.thegraysheet.com (paid subscription service).

Comparative Effectiveness Research Bill Passes.
On February 12, 2009, Congress passed President Obama’s economic stimulus package, including the provision calling for $1.1 billion in comparative effectiveness research. The final version of the package allows for research comparing cost effectiveness of treatments, as well as clinical effectiveness, raising industry concerns that the research will be used to determine Medicare coverage policies. However, the conference committee report accompanying the final bill noted that research findings should not be used to mandate coverage or reimbursement policies of public or private payers. Additional information is available at www.thegraysheet.com (paid subscription service).

Sunshine Act Revised to Prevent Duplication.
In a February 10, 2009, audioconference, Senate staff noted that the goal of the recently revised Physician Payments Sunshine Act is to prevent duplicate reporting requirements for industry. The revised bill still requires that firms report financial relationships with physicians, but also preempts any identical state reporting requirements that would result in duplicate reporting. That said, the revised bill does not seek to create a federal floor or a ceiling—states can still require reporting of other types of relationships not addressed in the federal bill. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA to Require More Oversight of Suppliers.
FDA intends to adopt the Global Harmonization Task Force final guidance on supplier control, which notes that manufacturers have ultimate responsibility for the quality of any products and services obtained from even second- and third-tier suppliers. The guidance adds that FDA authorities and third parties will inspect manufacturing firms for evidence that the firm is exercising control over these suppliers, otherwise the manufacturer could be deemed to be in violation of the Quality System Regulation. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Unique Identifiers Should Address Risky Products First.
As FDA tries to devise a standardized system of unique identifiers for medical devices, industry representatives say the agency should focus on the riskiest products first. At a recent workshop on the issue, FDA sought advice from industry regarding device identification standards, what information to include in a unique identifier, and which devices to exempt, among other things. FDA hopes to issue a proposed rule on the unique identifier system by the end of 2009. Interested parties can submit written comments at www.regulations.gov until February 27. Additional information is available at www.thegraysheet.com (paid subscription service).

Administration Official Weighs in on Cost-Effectiveness Research.
As Congress debates two comparative effectiveness research bills, President Obama’s top health policy official says comparing the cost of various health treatments—not just clinical effectiveness—could be helpful in health care reform efforts. Jeanne Lambrew told industry representatives at a recent conference that without some information on the cost of treatments, expanding health care coverage is impossible. The Obama administration included funding for comparative effectiveness research in its economic stimulus plan. The House of Representatives passed the bill without specifying that such research compare clinical effectiveness, while the Senate stimulus bill allows for clinical comparison research only. Additional information is available at www.thegraysheet.com (paid subscription service).

Daschle’s Withdrawal May Have Far-Reaching Effects.
Tom Daschle’s withdrawal from consideration for Secretary of Health & Human Services (“HHS”) may present challenges to the Obama administration’s efforts to effect health care reform. The loss of Daschle renders the new White House Office of Health Reform without a leader and many political appointments in question. Additionally, Daschle’s withdrawal may delay health reform and likely will shift power over the reform efforts to congressional leaders Sen. Max Baucus (D-Mont.) and Rep. Henry Waxman (D-Calif.). Additional information is available at www.thegraysheet.com (paid subscription service).

HHS Guidance Leaves Questions Unanswered.
Draft Guidance from the Department of Health and Human Services (“HHS”) regarding withdrawal of research subjects from clinical trials fails to address key issues, according to industry stakeholders. The Guidance issued in December 2008 has left researchers confused as to whether data analysis can include data gathered prior to a participant withdrawing from a study, and industry representatives say the guidance could limit valid scientific study. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Device Staff Refute Whistleblowers’ Claims.
Two former FDA scientists are disputing claims of corruption and improper coercion in the FDA medical device review process. Miriam Provost, former deputy director for science and engineering review at the Office of Device Evaluation (“ODE”), and Glen Stiegman, former ODE orthopedic devices branch chief and reviewer, both say that claims of corruption made by FDA whistleblowers in recent months seem inaccurate. The former reviewers say the allegations are not representative of their combined 18 years with FDA, and both note that coercion of device reviewers seems unlikely because ODE managers make the final decision on device submissions anyway. Additional information is available at www.thegraysheet.com (paid subscription service).

Device Industry Hopes for Senate Version of Stimulus Bill.
The House of Representatives last week approved President Obama’s $800-billion economic stimulus plan, which included $1.1 billion for research comparing the effectiveness of health care treatments and strategies. Industry representatives have expressed concern because the House bill fails to specify that the research focus on clinical effectiveness, not just cost effectiveness. Responding to these concerns, two senators introduced an amendment specifying that the research compare clinical effectiveness. The full Senate still needs to vote on the bill, but industry representatives hope that the amended language will trump the current House language. Additional information is available at www.thegraysheet.com (paid subscription service).

Globalization Act Addresses Oversight of Foreign Device Manufacturers.
The FDA Globalization Act of 2009 has been introduced in the House of Representatives, calling on foreign medical device manufacturing plants to register annually with FDA, if the manufacturers intend to export products into the United States. The Act also would create a body of inspectors dedicated to inspecting foreign facilities, to improve FDA’s oversight of foreign manufacturers. The House bill currently does not address the frequency of these foreign inspections, however. Additional information is available at www.thegraysheet.com (paid subscription service).