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...FDA Commissioner Scott Gottlieb, MD, announced that the Center for Drug Evaluation and Research would be taking steps to modernize the organization and functions of the Office of New Drugs in order to address scientific and medical advances within the industry. The goal is to make the review process more integrated across science and regulatory expertise. Janet Woodcock, director of CDER, plans on elevating the role of FDA scientists and medical officers and providing these officers with more tools and support “to advance the clinical and regulatory principles that the FDA uses to evaluate new drugs for safety and efficacy.”...Other changes will include the development of guidance documents, giving review staff more time with sponsors, and getting sponsors involved earlier in the development process. Engaging disease specialists, academic researchers, regulatory partners at other agencies, and patient groups is also a goal of CDER.

Allergan, which is selling its generics business to focus on branded drugs and aesthetics products, aims to acquire or license products that have already shown promise in studies, and leave the riskier discovery process to small biotechs and academic researchers...."The best way for us to participate in discovery is investing in a more 'virtual' sense, than actually building and running our own labs,"..

Payers who’ve balked at a new class of cholesterol meds now have more justification. A new study concluded that Amgen, Sanofi and Regeneron would have to slash their prices by more than two-thirds to make them worth the cost...Repatha (evolocumab) and...Praluent (alirocumab) are both sticker-priced higher than $14,000 per year...study comes from the Journal of the American Medical Association...authored by academic researchers...And its conclusions are strikingly similar to previous assessments...Researchers found that using the new PCSK9 meds, rather than...ezetimibe...would save $29 billion on care for cardiovascular complications over 5 years. But the cost of those drugs would run an estimated $120 billion...Reducing annual drug costs to $4,536 per patient or less would be needed for PCSK9 inhibitors to be cost-effective…The drugmakers have taken issue with those analyses, mostly for their assumptions that all eligible patients would be put on the drugs--an overly rosy projection for drug sales. Payers’ prior authorization hurdles are already restricting uptake; up to three-fourths of patients are being turned away...So far, both drugs have underperformed expectations...

Avoiding pre-market verification is downright easy…Theranos isn’t alone in avoiding regulation using an easily exploited loophole — in fact, it’s just one among many…Pathway Genomics, Admera Health, and Strand Life Sciences are diagnostics companies that offer cancer tests that impact people’s health care decisions. None of these companies have published data about their tests in peer-reviewed journals. Nor were any of these companies required to show regulators that their tests worked before they started marketing them to patients and physicians. That’s because each of these companies has been making use of what's known as the "laboratory developed test" loophole — which makes avoiding pre-market verification downright easy...Under the LDT loophole, any company that develops and conducts a diagnostic test in their own lab…can avoid submitting that test to the FDA before using it on patients. This get-out-of-regulation-free card exists because research hospitals often modify commercial tests. In the case of these hospitals, the academic researchers tend to publish their results anyway…The FDA knows this — even they’ve been calling LDTs a loophole — and the agency wants to change the way these tests are regulated…until that loophole closes, we’ll keep seeing companies using the LDTs as a dodge, because it’s a simpler and cheaper way to get to market. The real expense, of course, is patients’ health.