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Supreme Court Asked To Review Pay-To-Delay Deals
The controversy over the pay-to-delay settlements is moving up to the U.S. Supreme Court. Three pharmacy chains and a wholesaler have requested that the court review the issue. Their rationale is that they maintain that the deals stifle competition by delaying the arrival of lower-cost generics.
This has been an issue with the U.S. Federal Trade Commission; they have been lobbying Congress to enact legislation to restrict the settlements. This issue has also divided courts across the country, which is the reason the Supreme Court was asked to review the topic and settle the matter.
CVS, Rite-Aid, Arthur's, and Louisiana Wholesale argue that "the problem of exclusion payments and the proper liability standard is not abating-manufacturers used at least 40 exclusion payment agreements to restrict generic entry in the last two years. This case provides the court with its best opportunity to resolve the circuit split over the appropriate legal standard without having to address it in the context of a factual dispute as to whether a complex commercial arrangement between the brand and generic is actually a disguised exclusion payment."
http://www.pharmalot.com/2010/12/supreme-court-asked-to-review-pay-to-delay-deals/
House Members Boost Drug-safety Proposal
Democratic leaders in the House are trying to garner support for a bill that would give the FDA more resources to regulate the global drug marketplace. As more and more drugs are produced overseas, some congressmen say this presents an "alarming" risk to consumer safety.
The bill will:
- Create an up-to-date registry of all drug facilities-both foreign and domestic-serving American consumers
- Generate funding for increased GMP inspections for brand and generic drugs
- Require parity between foreign and domestic inspections
- Prohibit entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections
- Prohibit the entry of drugs into the U.S. lacking documentation of safety
- Require manufacturers to know their supply chain, identify and mitigate risk throughout their supply chain, and to document measures taken to secure their supply chain
- Prohibit false or misleading reports to the FDA
- Provide strong new enforcement tools, including mandatory recall authority, increased civil and criminal penalties, and new FDA authority to subpoena records related to possible violations
- Provide protection for whistleblowers that bring attention to important safety information
- Require unique identification numbers for drug establishments and importers to improve the ability of the FDA to more quickly identify parties involved in a crisis situation.
http://thehill.com/blogs/healthwatch/food-safety/134535-house-dems-boost-drug-safety-proposal
FDA May Implement Fees to Speed Generics Reviews
Generic-drug companies would face fewer factory inspections and save as much as a year developing products in exchange for paying fees for the first time under a proposal the FDA is evaluating.
Generic-drug reviews take 15 months longer on average than evaluations of brand-name products. Inspections take as much as 12 months to complete, especially for products made outside the U.S. Generally, getting the inspection scheduled in a timely manner is probably the biggest challenge both for the FDA and for industry.
Under the proposal, the FDA may waive "preapproval inspections" done after companies submit generic-drug applications and would rely on periodic inspections that focus on companies' broader manufacturing practices. The agency would continue with preapproval inspections when drugs are made with untested technologies or produced at a site the FDA hasn't inspected.
The FDA inspects U.S. plants once every 30 months, compared with once every 9 years for foreign plants, according to a September report by the Government Accountability Office. Eight to nine hundred generic-drug applications are received each year; this compares to about 100 applications for new brand-name drugs.
This concept is not new as brand-name drugmakers have paid the FDA fees since 1992 to help fund faster reviews.
http://www.post-gazette.com/pg/10350/1111262-28.stm
FDA Issues Warning Letter to Steris on Violations at Texas Plant
Sterilization products manufacturer Steris has received a warning letter from the FDA for quality-control and record-keeping violations at a Texas plant. The letter cited five violations at the company's Grand Prairie, Texas, contract sterilization plant (Steris operates 18 such plants in which it performs bulk sterilizations of other companies' products.).
Prompt action is required to address the violations as failure to do so could result in seizure, injunction, or financial penalties. FDA warning letters generally are considered by the FDA to be informal and advisory and are a fairly routine part of doing business for medical device firms. For the last year, the company has been dealing with another, far more serious issue, with the FDA, involving a new sterilization system for heat-sensitive medical instruments.
In the current letter, many of the violations are procedural. As an example, the company was cited for failing to establish a procedure for how many humidity monitors should be placed in a load of finished medical devices that's being sterilized. The company was also cited for failing to maintain records to show that device sterilization met the standards of its customers.
http://www.medcitynews.com/2010/12/steris-gets-fda-warning-letter-on-violations-at-texas-plant/
(Note: When Steris was closed down a few years ago, there were numerous drug shortages, some of which were supplied by compounding pharmacists.)
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