|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 01-19-2006
FDA Issues New Rules For Drug Labels --- Move Is Designed to Clarify Safety Data For Patients and Physicians
The FDA has effected what may turn out to be one of its most important safety innovations in decades: labeling changes that make it easier for doctors and patients to read and understand the clinical benefits (and risks) of FDA-approved medicines. The new labeling format replaces an arcane system that was burdened with complicated jargon and buried critical information in pages of minutiae.
For the first time in more than 25 years, the Food and Drug Administration is revamping the format of prescription-drug labels, a move designed to make it easier for physicians and consumers to get clear information about medications. Drug labels -- sometimes called the package inserts -- are notoriously complicated documents, printed in tiny script that can stretch on for dozens of pages. Written primarily for doctors, they contain FDA-approved information on dosage and side effects. But patients and doctors alike have complained that the inserts are confusing, and there is evidence that physicians don't always follow the labels' recommendations. The new label rule, which has been in the works for several years, reorganizes the inserts into a more easy-to-follow, standardized format. The plan also includes a government database that will ultimately allow people to search for the information online at dailymed.nlm.nih.gov. …
The biggest change to the labels will be a new summary at the beginning called "Highlights." Like the nutrition box that appears on food packages, the new highlights section is designed to telegraph the most important information at a glance, using a standardized format. It will summarize the major uses and side effects of the drug, as well as dosing.
The labeling change has taken years to implement, but is an important signal that the agency is serious about making drug information more consumer friendly. Much remains to be done to empower consumers and physicians to make better treatment choices, but Acting Commissioner Von Eschenbach should be commended for this initiative.
Lawyers May Change Their Tactics in Drug Liability Cases
The FDA, as expected, has issued a new labeling rule that tries to preempt state tort claims, at least in certain cases. If effective—and there is some question about whether state courts will recognize the agency’s authority—it could cancel out much of the frivolous litigation that now handicaps the pharmaceutical industry.
The agency yesterday declared the pre-emption policy in the preamble of a regulation that lays out a new format for drug labeling. The FDA's move drew quick complaints from plaintiff attorneys and state officials, who argued that the agency was overstepping its bounds. But drug makers said that they supported the FDA's decision and that the agency should determine how safety information is communicated.
In the rule, the FDA said that under the law, its approval of labeling "pre-empts conflicting or contrary state law," including statutes that deal with requirements to warn consumers about potential side effects. The rule gave specific cases in which such pre-emption would apply, but added that it was true in "at least" those situations. It also said pre-emption would apply to cases against health-care providers that deal with claims that they failed to tell patients about a risk "beyond what is included in the label."
The move is likely to spark a fight in Congress. Republicans won't be eager to move against the FDA, so it isn't clear if a bill would make much headway, because they are in the majority. Sen. Edward M. Kennedy (D., Mass.) called the pre-emption language an "abuse."
Actually, the only abuse we can see is that plaintiffs’ lawyers have portrayed vaccine and pharmaceutical companies as the next “Big Tobacco.” If there is any area where the federal government’s commerce power should trump state laws, this is it. Today, the industry is subject to endless litigation based on a patchwork of state laws. This allows plaintiffs’ attorneys to “forum shop” for friendly juries and judges, impedes pharmaceutical innovation, and drives up the cost of new medicines.
Jim Copland, director of the Manhattan Institute’s Center for Legal Policy, said in response to the FDA’s new labeling that “the FDA's decision that its labeling decisions preempt many state causes of action is a common-sense interpretation consistent with the constitutional principle that the federal government has primary authority over regulating interstate commerce. The FDA goes through an extensive review process to determine the precise labeling that is most appropriate to warn consumers, and states should not have the power to interfere with these decisions by allowing lay juries to second-guess the FDA.”
A weapon against stroke; Until now, only medicine could open fragile brain passages
Blood thinners are one of the primary treatments for transient ischemic strokes, but they also can cause dangerous bleeding in the brain. Unfortunately, stents that are regularly used to clear blockages in arteries leading to the heart are too inflexible to be used to clear the convoluted arteries leading to the brain. Researchers, however, have designed a new stent that may be useful in a certain subset of stroke victims.
“Current medicinal treatment is just not good enough,” said Dr. Demetrius Lopes. Among the first in the nation to use the new Wingspan Stent System, Lopes believes this surgical treatment will reduce the 60,000 strokes caused by [intracranial atherosclerotic disease]. “Out of all the developments in vascular therapy…only this landmark technology with actually open the clogged brain vessel.”
The flexible Wingspan Stent, made by Boston Scientific and approved by the Food and Drug Administration last August, revolutionizes neurovascular stent surgery.
"Cranial blood vessels are more fragile and tortuous to navigate because of their many twists and turns," Lopes said. Because of this, the inflexible stainless-steel stents used to prop open clogged heart arteries do not work well in the brain. This new brain stent, made of a nickel and titanium alloy called nitinol, can curve or taper and reach areas of the brain that could not be treated surgically before.
More research still needs to be done to establish the stents’ safety and efficacy record. However, it is a welcome innovation for a disease that is one of the nation’s leading causes of death and disability.
Plaintiff’s paradise waits for latest Vioxx trial
What do product liability suits and real estate markets have in common? In both cases, the value of the underlying commodity is determined by location, location, location.
The plaintiff’s bar uses Vioxx as the paragon case of pharmaceutical companies putting profits before public health. What it really shows is how our legal system penalizes companies regardless of the actual evidence or science underlying the lawsuits, because attorneys routinely use forum shopping and inflammatory rhetoric to get juries to produce multi-million dollar verdicts.
Leonel Garza was 71 when he died of a heart attack, 23 years after being diagnosed with heart disease and decades after a heart attack and a quadruple bypass.
But his lawyers who are suing Merck & Co. say it was the Vioxx that he took for arm pain for 17 days that killed him. Jury selection is scheduled to begin Tuesday in Rio Grande City, a town of about 12,000 people less than five miles from the Texas-Mexico border. …
"What you're seeing is a case that is strong in the merits for Merck but has got to be balanced on the challenges Merck will face in that jurisdiction," said Peter Bicks, a New York City lawyer who has successfully defended large companies in Texas and has been watching the Vioxx litigation. "This jurisdiction has been viewed as one of the toughest jurisdictions for corporate defendants in the country."
From a company’s perspective, whether we’re talking about vaccines, hormone replacement therapy, or Vioxx, you’re damned if you do, and dammed if you don’t. Even a responsible company that adheres to the best available science and complies with all relevant FDA regulations can be hammered by attorneys in places like Rio Grande City, Texas.
Without reliable rules to protect them from frivolous litigation, companies have a disincentive to aggressively pursue rare safety signals that might help physicians and patients use drugs more safely. FDA preemption of state tort liability, combined with a fair and rational system of injury compensation, would go a long way to making everyone safer and spurring more innovative drug research.
Alzheimer’s drugs policy reviewed
Britain’s National Institute for Clinical Excellence (NICE) has proposed draft rules on the use of several Alzheimer’s drugs that are stirring anger and controversy among doctors and patient advocates in the UK.
Donepezil, rivastigmine and galantamine would be funded but only when new patients reach a moderate stage of the condition…Campaigners are angry that thousands of patients would not be entitled to the treatments in the early stages. A fourth drug, memantine, which is used in the later stages of Alzheimer's, will not be funded for new patients - because NICE says there was not enough evidence of its clinical benefit. …
There was an outcry last March when NICE suggested that all four drugs should not be funded by the NHS because they were not cost-effective. …
Neil Hunt, from the Action on Alzheimer's Drugs alliance, said: "The new draft guidance still raises serious ethical and practical concerns. "People with dementia and their carers value the benefits that the drug treatments bring in the early stages of the disease….For what other condition would you wait until people decline so much that they can no longer look after themselves before giving them treatment?"
NICE’s draft policy may also throw up new hurdles to the development of new Alzheimer’s treatments. While it is understandable for NICE to want to use the most effective drugs available, restricting access to treatments that offer incremental advances or that are used in early-stage Alzheimer’s reduces incentives for companies to bring new treatments to market. While every company hopes to market a breakthrough drug treatment, the reality is that science doesn’t produce miracles on demand. Policymakers need to pay as much attention to how coverage decisions affect incremental drug innovation over the long-term as they do to short-term budget considerations.
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