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There’s a lot of buzz about FDA seeking criminal prosecution of industry executives caught up in quality control problems. FDA has sweeping authority to follow through on those threats—and they’ve been talking about it for long enough that there’s really no excuse for failing to be prepared already.
FDA is working along a parallel path to other several other government agencies to find ways to stimulate drug development for anti-infectives active against resistant strains. Top policy leaders in the drug review divisions reflect the new interest by thinking aloud how historical controls or oncology-like accelerated approvals might speed the process
An effort to identify early biomarkers of antibiotic efficacy is turning toward patient assessments of drug activity. FDA and industry scientists are both participating in the biomarker effort. The attention to patient observations reflects a growing interest at FDA.
FDA’s push to encourage development of new antibiotics requires getting past data integrity issues in the class. The agency’s workshop on antibacterial clinical trials revealed a range of efforts aimed at better Good Clinical Practices compliance – and those efforts can just as easily be applied to other drug classes.
July 2010 was the hottest month on record in Washington, DC—and it was even hotter for the FDA new drug regulatory group. The month featured one hot topic after another—Avandia, Qnexa, opioids, REMS, Avastin, Brilinta, Lovenox. Here are 10 themes to think about heading into the fall.
Going into the Avandia re-review, FDA looked stuck between a rock and a hard place. Coming out of the FDA advisory committee meeting, the agency has a full set of options to choose from that would likely be viewed as a credible outcome by the public. But possible surprises remain.
FDA’s advisory committee members seem to be adopting the new post-marketing REMS authority with more enthusiasm than FDA’s own staff. Many of the advisory committee members – especially people who have served on the Drug Safety & Risk Management Advisory Committee – are jumping at the middle ground solution (between approval and rejection) offered by REMS. The Avandia re-review on July 13-14 demonstrated the strong appeal of REMS in a tough regulatory situation.
The combined Anesthetic & Life Support Drugs and Drug Safety & Risk Management advisory committees voted strongly (25-10) against FDA’s proposed class-wide educational REMS for long-acting opioids; but the vote does not stop the process. In fact, FDA may have achieved much of what it set out to do by just by proposing a class REMS in the area.
AstraZeneca won two strong votes (each 7-1) in favor of approval of its clot busting drug Brilinta (ticagrelor) from FDA’s Cardio-Renal Drugs Advisory Committee on July 28. Standing between the drug and final FDA approval, however, is an unusual request from the advisory committee for a supporting Phase IV efficacy study in the same indication as the approval.
FDA faces a tough decision on Avandia. Should it stay or should it go? There is bigger underlying issue: should the standard be different for pulling a drug than it is for approving the drug in the first place? It may be counterintuitive, but a different standard makes sense.
If you need evidence that the regulatory climate has improved at FDA since 2007, look no farther than FDA’s handling of Vivus’ weight loss drug Qnexa: FDA’s review team was ready to take a risk on the drug despite a number of safety signals that would most likely have killed a product three years ago. But if you want to know how fundamentally the regulatory model has changed, listen to what the committee said in rejecting the application.
FDA’s Endocrinologic & Metabolic Drugs voted 10-6 against approval of Vivus’ weight loss drug Qnexa (phentermine/topiramate) at this time. But committee members were almost unanimous in agreeing that it was a very close call, and their comments captured the nuance of the many issues FDA must resolve in the context of reviewing weight loss drugs in general and this application in particular. Below is our transcript of the discussion by each panelist about the reasons for their vote.
The 340B program got a lot of attention from pharmaceutical industry lobbyists during the health care reform debate. Now it may be getting more attention from the commercial side of the business. Expanded discounts remains a legislative threat—but increased sales to “safety net” purchasers is also a business opportunity.
How big an impact do the new Medicaid rebate rules have on prices? There's no way to tell for sure, but prices files analyzed for the 340B program offer a pretty good clue.
The National Organization for Rare Disorders wants FDA to be a bit more rigorous in communicating its regulatory standards. The agency has always been flexible in determining how much evidence of safety and efficacy is necessary when it comes to orphan drugs; sponsors, investors and patients would benefit if that is more clearly spelled out.
