Lori A Carr The US Food and Drug Administration (FDA) would get a sizeable increase in its funding
under a new budget proposal released by the Obama Administration on 10 April 2013, but much of that funding comes in the form of user fees, reflecting some of the realities of an austere budget environment.
As the full implementation of the Affordable Healthcare Act draws closer, shifts and
changes are taking place within the industry. Medscape has released its Physician Compensation Report 2013, which reflects that income is up, frustrations still exist, and healthcare reform is making a definite impact on physician practices. Currently, 24 percent of physicians participate in an accountable care organization, compared with 8 percent last year.
ReGen Biologics, Inc. (“ReGen”), which has been acquired by Ivy Sports Medicine, LLC (“Ivy”), filed suit in 2011 challenging FDA’s authority to rescind the 2008 510(k) substantial equivalence determination for the company’s “Menaflex” product, a collagen meniscus implant intended to reinforce damaged meniscal soft tissue. ReGen Biologics, Inc. v. Sebelius, No. 1:11-cv-01006 (D.D.C. filed May 31, 2011).
Fraudulent Versions of Botox Found in the United States: FDA is alerting health care practitioners and the public that fraudulent versions of Botox that are not approved by the FDA are being sold to U.S. medical practices. The outer carton is counterfeit, while the vial inside is labeled as a foreign version of Botox, which is not FDA-approved for sale in the United States. These products are being sold by unlicensed suppliers who are not part of the legitimate U.S. supply chain. FDA cannot confirm that the manufacture, quality, storage, and handling of these products follow U.S. standards. These fraudulent products are considered unsafe and should not be used.
The U.S. Food and Drug Administration is requesting a budget of $4.7 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2014 budget. Industry user fees would fund 94 percent of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA’s ability to oversee imported food.
Lori A. Carr, Inc. receives a response from the Colorado State Senator’s office regarding the
Medical Device Tax
Testifying before a US House of Representative hearing on mobile medical technology on
March 21st, FDA official Christy Foreman indicated that the agency’s approach to mobile medical app oversight will not include smartphones or tablets used to access such devices.
A pair of House Republicans promise to take a closer look at the FDA, calling for an independent advisory committee to help provide insight and point out areas of improvement at the federal watchdog agency.
There appear to be a few glimmers of constructive activity in Washington, D.C. Last week, the Senate moved the ball forward on an issue that is extremely important to innovation and jobs in the United States. By passing an amendment to repeal the medical device tax by an overwhelming 79-20 votes, the Senate has done the right thing for patients and the U.S. economy.
The purpose of the workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible. This public workshop aims to engage stakeholders in active discussion with FDA and to encourage public comments regarding standard content and format for medical device labeling and the use of a repository containing medical device labeling.