05/23/2012
A Sacramento Bee opinion piece by Kathy Kneer -- president and CEO of Planned Parenthood Affiliates of California -- and Julie Rabinovitz -- president and CEO of California Family Health Council -- argues that California lawmakers should approve a bill, by Assembly member Holly Mitchell, that would "authorize registered nurses in community clinics to dispense birth control under a standardized procedure." They conclude, "By passing this common-sense law, California will continue to be a leader in preventing unintended pregnancy and can remind the rest of the nation that the war on women stops here." Sacramento Bee.
05/23/2012
Yesterday, Senate Majority Leader Harry Reid urged lawmakers to reach a deal on amendments to a bill to reauthorize FDA's prescription drug and medical device user fee programs. If a deal is not reached, Reid said he will move on to other legislation. The Hill's "Floor Action Blog" et al.
05/22/2012
On Monday, a three-judge panel of the U.S. 9th Circuit Court of Appeals ruled that medical marijuana users cannot use a federal disability law to argue against the shuttering of medical marijuana dispensaries. Medical marijuana advocates had alleged that the cities of Costa Mesa and Lake Forest in Orange County violated the Americans With Disabilities Act by closing the dispensaries. Judge Raymond Fisher wrote, "We recognize that the federal government's views on the wisdom of restricting medical marijuana use may be evolving," but "for now Congress has determined that, for purposes of federal law, marijuana is unacceptable for medical use." Los Angeles Times, San Francisco Chronicle.
05/18/2012
Between 2001 and 2010, FDA approved more new drugs in less time than regulators in Europe and Canada, according to a study published Wednesday in the New England Journal of Medicine. The median time for FDA to review a drug was about 10-and-a-half months, which was about 45 to 70 days faster than the European Medicines Agency and Health Canada. FDA reviewed nearly 225 drug applications over the decade, 40 more than EMA and nearly 125 more than HC. AP/Sacramento Bee.
05/18/2012
The Senate has started debating a bill to reauthorize and modify FDA's prescription drug and medical device user-fee programs. Some stakeholders discussed adding language to the bill to create a national system to track prescription drug safety. The Hill's "Healthwatch" et al.
05/09/2012
Yesterday, a House panel unanimously approved legislation to modify FDA's user-fee programs for drugs and medical devices and extend the programs for an extra five years. The House Energy and Commerce Committee is expected to mark up the bill tomorrow. Politico et al.
05/09/2012
The Senate Finance Committee has started investigating ties between drugmakers, advocacy groups and organizations that set painkiller prescription guidelines. Meanwhile, the American Pain Foundation said it will dissolve for financial reasons. New York Times, Washington Post.
05/08/2012
On Tuesday, the House Energy and Commerce Subcommittee is expected to mark up legislation that would reauthorize and modify the Prescription Drug User Fee Act. The full committee is expected to consider the bill on Thursday. Industry sources say the committee hopes to move the bill to the floor under a suspension of rules, a sign that it could move quickly. Politico.
05/08/2012
In a statement released last week, House Minority Leader Nancy Pelosi criticized the Obama administration's recent closures of medical marijuana dispensaries in California and expressed support for policies to strengthen the rights of users. Pelosi said in the statement that the administration's actions "undermine a policy that has been in place under which the federal government did not pursue individuals whose actions complied with state laws." The Hill's "Healthwatch."
05/04/2012
NIH has announced an initiative that seeks to find new uses for old drugs that did not adequately treat one disease but might be effective for another. For the program, drugmakers will provide about 20 compounds to biomedical researchers. AP/San Francisco Chronicle et al.
05/03/2012
AARP has joined a class-action lawsuit alleging that a physician at a Ventura County nursing home -- the Ventura Convalescent Hospital -- violated state law when he administered antipsychotic drugs to residents without obtaining their consent or the consent of their families. The case could involve as many as 100 plaintiffs. Ventura County Star.
05/02/2012
An Institute of Medicine report recommends that FDA do more to monitor the safety of prescription drugs after they are on the market. According to the report, FDA should take a "life cycle" approach by conducting safety trials both before and after a drug is approved. Reuters et al.
04/26/2012
Yesterday, the Senate Health, Education, Labor and Pensions Committee approved a bill to reauthorize user fees that drug and medical device makers pay to FDA for a quicker review of their products. A similar measure stalled in a House committee. The Hill's "Healthwatch" et al.
04/25/2012
This week, leaders of a House health subcommittee and a Senate health committee are expected to release a series of proposals to reauthorize FDA's prescription drug and medical device user fee programs. The programs are set to expire in September. Politico et al.
04/24/2012
The California Assembly is considering legislation that would address health insurers' use of step-therapy, in which patients are asked to try as many as five prescription painkillers before health plans agree to cover the drugs. Under the bill, insurers would be prohibited from asking patients to try more than two prescription medications before providing coverage. KQED's "The California Report."