FDALegislativeWatch

House Republicans Seek Top Down Change To FDA's Warning-Letter Appeals

This article is reprinted from "The Tan Sheet" – November 26, 2007

FDA leadership needs to review the agency's enforcement dispute resolution process, according to ranking Republicans on the House Energy and Commerce Committee.

BIO Challenges Comparative Effectiveness Application In White Paper

All three of the major medical product trade associations are emphasizing that any comparative effectiveness program developed by the government should be enhancing physicians' judgments, but their somewhat different communication strategies illustrate the varied challenges each of the sectors face.

The Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization both note how comparative effectiveness studies can improve decision-making by doctors. However, such data should not supplant individual judgments in the care of particular patients.

With ICD Leads Under Scrutiny, FDA Expects To Update Guidance In 2008

FDA plans to release new PMA guidelines for pacemaker and implantable defibrillator leads in 2008 to give manufacturers more guidance on bench testing.

"We're bringing the document up to what companies are doing already, which is a larger battery of tests," Megan Moynahan, chief of CDRH's Pacing, Defibrillator and Leads review branch told "The Gray Sheet."

Comparative Effectiveness Requires Openness To Variety Of Data - CBO Chief

The development of comparative effectiveness will require increased flexibility in the types of data researchers may consider, with observational data taking on a more significant role, Congressional Budget Office Director Peter Orszag suggests. Orszag spoke at a Nov. 13 press gathering to unveil the CBO's long-term outlook for health care spending.

Randomized clinical trials are generally viewed as the gold standard for evaluating medical products and services, he acknowledged. However, "it is implausible to me that to build out the evidence base that will be necessary for [comparative effectiveness research] that you are going to be able to rely exclusively on randomized control trials. I believe the medical profession will inevitably have to rely on the imperfections of econometric analysis of panel set data."

FDA Employee Misconduct Charges To Be Investigated By OIG Instead Of Itself

The new Democratic-controlled House Energy and Commerce Committee's first public oversight activity of FDA is focusing on potential conflicts of interest in the agency's contract awarding practices.

In a Jan. 22 letter to Commissioner Andrew von Eschenbach, the committee requests all records relating to a 2005 FDA internal investigation of a contract awarded to Platinum Solutions, a software development firm.  The committee has not yet opened a formal investigation and has not scheduled any hearings related to the issue.

Part D Claims Data Sharing: Lack Of Progress Gets MedPAC's Attention

The Medicare Payment Advisory Commission appears to be renewing its interest in shaking loose Part D claims data from CMS to help inform questions about drug access and health care quality under Medicare. The issue arose during discussion of the Medicare Part D program during a Nov. 8 MedPAC meeting in Washington, D.C. Panelists expressed disappointment that a CMS proposed rule on Part D data sharing has languished since it was published in October 2006.

FDA Should Track Inclusion Of Seniors In Clinical Trails More Carefully - GAO

A report by the General Accountability Office concludes that the FDA rules for drug approval fail to guarantee the safety and effectiveness of drugs for seniors.

Prepared for Rep. Henry Waxman, D-Calif., and Sen. Edward Kennedy, D-Mass., the report finds that about two-thirds of medical officer reviews examined by GAO included a discussion of the safety and effectiveness for elderly patients, and one-quarter of reviews discussed the "sufficiency of representation of elderly persons."

FDA's DTC Pre-Review Authority Will Face Court Challenge, Lawyers Predict

FDA authority to require pre-review of direct-to-consumer television ads "likely will be tested at some point in the courts," David Ogden of WilmerHale predicted during an Oct. 31 audioconference on the FDA Amendments Act. Questions about the constitutionality of a moratorium on drug ads caused Congress to abandon that approach to DTC regulation when it wrote FDAAA. Instead, the law gives FDA discretion to delay a TV ad while the agency determines if the ad must be changed to include disclosure of a serious risk and the date of the drug's approval. FDA also can recommend changes needed to protect "consumer good and well-being."

FDA Names New Advisors To Help Communicate Risk

FDA announced Nov. 5 that it has selected 15 voting members to serve on its Risk Communication Advisory Committee, which is to advise the agency on how best to communicate the risks and benefits of regulated products. The lineup includes risk communication experts, academics, public affairs specialists, consumer advocates and a broadcast journalist.  FDA chose the members from more than 240 nominations.

Increased FDA Authority Over OTCs Sought in Waxman Bill

The Non-Prescription Drug Modernization Act, introduced Nov. 6, would give FDA authority to quickly amend or repeal OTC drug monographs without being required to pursue notice and comment rulemaking as currently required under the Administrative Procedures Act.