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Faster Approval Possible for Drugs for Unmet Needs
A plan that would allow agency approvals based on the second of three phases of clinical trials, when data can't be "ethically, feasibly, or practicably generated, is being proposed.
The renewal of PDUFA may include proposals to fast-track evaluations of medicines for conditions with no approved cures. This plan would let manufacturers such as GSK to bypass customary clinical trial requirements before bringing products to market.
While the FDA occasionally grants exemptions, experience to date of many biotechnology companies is that the criteria for utilizing this type of regulatory flexibility are unclear and unpredictable. Targeted diseases are those rare disorders affecting fewer than 200,000 patients in the U.S. About 360 drugs exist for 7,000 such conditions. Under this proposal, manufacturers can conduct shorter trials on patients based on a measured effect of a drug instead of an actual clinical outcome.
http://www.bloomberg.com/news/2011-11-16/drugs-for-unmet-needs-may-get-faster-approval-under-senate-plan.html
More Information on Alerts About Drug Risks Requested from FDA
The Archives of Internal Medicine has published a two-page research letter written by physicians that said about half of the potential "safety signals" about adverse events listed on the FDA's website from 2008 to 2010 resulted in labeling changes but without guidance as to seriousness and what action should be taken. They state that the concern is that the current recommendations to healthcare professionals and consumers is to not take any action on listed potential safety signals, even though each of these signals are of serious risk.
http://prescriptions.blogs.nytimes.com/2011/11/15/f-d-a-is-urged-to-issue-more-alerts-about-drug-risks/
Supreme Court to Review Healthcare Law
The Supreme Court announced that it will hear challenges to the new healthcare law. The result of the ruling may provide insight as to the federal government's power to address pressing social problems, specifically how to ensure medical coverage nationwide. The main question is whether Congress exceeded its power to regulate interstate commerce by requiring most Americans to buy insurance by 2014 or face a tax penalty.
http://www.usatoday.com/news/washington/judicial/story/2011-11-14/supreme-court-health-care/51194696/1
Scorpion Antivenom is Exorbitantly Priced
The FDA approved scorpion antivenom, which was hailed as an important tool to protect vulnerable victims from scorpion stings. However, as doctors and patients are now discovering, the fast-acting serum for those who are stung by scorpions comes at a very steep price; as much as $12,467 per vial of the antivenom approved to help children, the elderly, and others quickly recover from severe reactions from scorpion stings.
Therapy requires a typical dose of three to five vials to counteract the venomous sting resulting in hospital bills for patients and their insurance companies that can exceed $62,000.
The price is ridiculously high says a scientist who advises Mexico-based Instituto Bioclon, which makes the drug. The Mexican biotechnology company produces more than 250,000 vials for Mexican residents, who are charged about $100 per vial at pharmacies in Mexico or even less at government-funded clinics for a drug that is administered intravenously.
The cost inflates when the serum is sold in the U.S. because each link in the U.S. supply chain raises the price. The problem is being addressed by health insurance companies that are still trying to figure out a fair price to reimburse health providers.
http://www.azcentral.com/business/articles/2011/11/10/20111110scorpion-drug-cost.html
J&J Says There are Limited Options for Doxil Shortage
Johnson & Johnson admits the company has few options for fixing its supply problems. The company states that there's little J&J can do to resolve the problem because J&J contracted out its Doxil manufacturing to Ben Venue Laboratories, a unit of Boehringer Ingelheim that has been struggling to fix a series of production problems—including manufacturing shortfalls flagged by the FDA. It seems that J&J doesn't have the power to move in and fix Ben Venue's problems, especially considering that J&J has had a lot of manufacturing problems of their own.
Other options to resolve the production difficulties on the part of the independent specialty manufacturer are limited; so, patients remain on the Doxil waiting list. Clinical trials of other cancer drugs in combination with Doxil—or in comparison with Doxil—remain on hold.
http://online.wsj.com/article/BT-CO-20111109-718018.html
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