Author Archives: Jill Wechsler

FDA, Drug Companies Struggle with Compassionate Use Requests

A national publicity campaign recently succeeded in obtaining early access to an experimental treatment for a seriously ill child, touching off a broader discussion of compassionate use policies and their impact on drug development and approval. As 7-year-old cancer patient Josh Hardy gained relief from a life-threatening infection following a bone marrow transplant thanks to […]
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Medicare Data Raises Questions About Drug Costs

The recently released Medicare data on payments to individual doctors doesn’t provide specifics on prescription drug outlays, but opens the door to scrutiny of Medicare reimbursement for medicines delivered in physician offices, writes Jill Wechsler. The Centers for Medicare and Medicaid Services (CMS) has released data on payments to some 880,000 healthcare providers who collectively […]
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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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