Policy and Medicine

Drug Information Association: Comparative Effectiveness Conference

2012-02-15T05:28:00-05:00

We have recently seen a lot of activity regarding the Patient-Centered Outcomes Research Institute (PCORI), an independent, non-profit health research organization. PCORI will have an estimated $3 billion over the next decade to fund CER. The Patient Protection and Affordable...

Road to Reform: The Healthcare Regulatory Burden

2012-02-15T05:01:00-05:00

A recent article from California Healthline looked at some of the regulatory problems our health care system is facing and some of the solutions to those problems that are currently underway. The article started off by noting that although President...

ACCME Launches New Website

2012-02-14T09:02:40-05:00

The Accreditation Council for Continuing Medical Education (ACCME) announced the launch of their redesigned Web site. The purpose of the Web site redesign is to offer a more user-friendly resource with improved navigation, organization, content, and design. The site’s restructuring...

The Difficulty and High Costs in Creating New Medications

2012-02-14T05:47:00-05:00

Over the past several years, there has been significant discussion about the difficulty pharmaceutical and medical device manufacturers face bringing a product to market. As a recent article from David Shaywtiz noted, “the difficulty of creating new and better medicines...

FDA Issues Draft Guidance’s on Bio-Similars

2012-02-13T05:42:00-05:00

The U.S. Food and Drug Administration (FDA) last week issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product Quality Considerations...

FDA Using Accountability to Deter Illegal Marketing Activity

2012-02-10T05:51:00-05:00

Using accountability as a tool to deter illegal activity like misbranding and promote corporate transparency was a resounding theme during a discussion last year held by the Food and Drug Law Institute (FDLI). The discussion, moderated by Alan R. Bennett,...

FDA CDRH – MDUFA Agreement and Strategic Priorities for 2012

2012-02-09T05:49:00-05:00

The FDA and industry recently came to an agreement in principle for the Medical Device User Fee Act (MDUFA), costing the device industry $595 million over the next 5 years. With hearings scheduled in the house for next Thursday on...

Physician Payment Sunshine Act: CMS Proposed Rule – Links to Legal Resources and Questions

2012-02-08T09:11:55-05:00

The February 17th deadline is quickly approaching for individuals and stakeholders to submit comments for the proposed regulations from the Centers for Medicare and Medicaid Services (CMS) that will implement the Physician Payment Sunshine Act (Section 6002 of the Patient...

Hospitals Hire Sales Reps to Recruit Referrals

2012-02-08T05:42:00-05:00

Typically, when we think of sales representatives, we see the image of a man or woman dressed in a suit, entering a doctor’s office to promote the latest new drug or device. These sales representatives usually work for major pharmaceutical...

Convergence of Interest - Not Conflict of Interest

2012-02-07T06:04:00-05:00

Given all the recent coverage of the proposed regulations implementing the Physician Payments Sunshine Act (Section 6002 of the Affordable Care Act), there has been an increasing focus on the issue of “conflicts of interest” that may arise from physicians...