Medical Device Blog – QA & Regulatory Updates from Emergo Group

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

US Government to Require Device Manufacturers to Disclose Payments to Doctors

The Obama Administration has announced plans to require medical device and pharmaceutical companies to report payments they make to US doctor and other health care providers for research, consulting and travel.

According to a recent New York Times report (tiered subscription required), the new rules are designed to tackle influence these payments have on doctors’ treatment decisions; payment from a medical device manufacturer to a doctor has the potential to make it likelier that that doctor will prescribe that manufacturer’s device instead of cheaper alternatives, evidence suggests.

The new rules will require companies with at least one product covered by Medicare or Medicaid to disclose all payments to doctors who are not their own employees. Payment data they provide will be published online.

Types of payments falling under these requirements include compensation for development, assessment or promotion of new products as well as royalty payments to inventors, payments to teaching hospitals for research and even “$25 worth of bagels and coffee to a doctor’s office for a meeting.” Companies’ chief executives, chief financial officers and/or chief compliance officers must attest to each report’s accuracy.

Administration officials believe more than 1,100 firms will be impacted by the new rules; failure to comply will incur penalties of up to $10,000 for each payment a firm fails to disclose. Knowingly failing to report payments will incur penalties of up to $100,000 per violation, capped at $1 million per year.

The Centers for Medicare & Medicaid Services (CMS) is accepting public comment on the rules through February 17^th, after which final rules will be implemented.

Markets: USATags: CMS, Medicaid, medical device, Medicare, new york times

Author: Stewart EisenhartDate: January 23, 2012

Venture Capitalists Lobbying Congress Heavily to Reign in FDA

Venture capitalists are spending significantly on efforts to lobby the US Congress to ease FDA regulatory requirements for medical device manufacturers, to considerable effect.

According to a New York Times report, venture capital funds allocating to medical device and technology manufacturers have provided more than $3.3 million in political donations to lawmakers and political action committees over the past five years; 20% of those donations were made to politicians and groups explicitly advocating less regulatory authority for the FDA in terms of medical device reviews.One lobbying group, the National Venture Capital Association, spent $350,000 last year on medical device and health care efforts, and expects that figure to increase to $450,000 for 2011.

Now that the FDA’s Medical Device User Fee law is up for renewal in Congress, medical device industry and venture capital lobbying efforts appear to be paying off. No less than 10 bills have been introduced by House Republicans since early October, along with a bipartisan Senate bill, all aiming to speed up the FDA’s medical device review process. Industry efforts to repeal a looming sales tax on medical device manufacturers mandated by the Affordable Care Act have also gained support among lawmakers from states such as Massachusetts and Minnesota with sizeable medical device sectors.

Although the merits of their arguments have been questioned by various medical experts, industry and VC advocates have so far effectively steered the conversation in Congress.

Markets: USATags: 510(k), 510k, FDA, medical device, new york times, venture capital

Author: Stewart EisenhartDate: October 26, 2011