Author Archives: Jill Wechsler

Medicare Payment Data Raises Questions About Drug Costs

Even though the just-released Medicare data on payments to individual doctors doesn’t provide specifics on prescription drug outlays, it opens the door to sharp scrutiny of Medicare reimbursement for medicines delivered in physician offices. The Centers for Medicare and Medicaid Services (CMS) has released data on payments to some 880,000 health care providers who collectively […]
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FDA Wants YOU!

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and Center leaders are looking for experienced industry managers to help rebuild its staff. Many experienced FDAers are ending their careers or taking on new challenges, creating a need for “renewal and replenishment” of the agency, […]
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FDA, Sponsors Seek Study Endpoints Earlier in Development

As payers demand more evidence documenting medical product value, biopharma companies are responding by moving sooner to decide key clinical outcomes to measure. While clinical trials still have to document product safety, efficacy and quality, sponsors also look to demonstrate suitability for formulary placement and reimbursement. Food and Drug Administration officials support these strategies to […]
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Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by the Food and Drug Administration with labeling that links prescribing to specific biomarker measures, health plan operators, […]
Posted in FDA, Gene therapy, Legal, Market Access, R&D, Regulatory, Technology | Tagged , , , , , , , , , | Leave a comment

Social Media Raise Concerns for Marketers, Trial Sponsors

While biopharmaceutical companies are using websites and third-party postings to provide information on medical products — despite a host of regulatory issues — social media use is in its infancy related to the design and conduct of clinical trials. A recent report from the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) finds that […]
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