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[News] New regulations proposed for off-label uses of drugs, devices — ScienceDaily

New regulations proposed for off-label uses of drugs, devices — ScienceDaily.

Excerpts

Date:January 22, 2015
Source:University of California, Los Angeles (UCLA), Health Sciences
Summary:Researchers have proposed a system for off-label drug prescriptions combining reporting, testing and enforcement regulations, and allowing interim periods of off-label use. This would give patients more treatment options while providing regulators with evidence of the drugs’ safety and efficacy.

 

Medicine drugs

Medicine drugs (Photo credit: Wikipedia)

Off-label use of drugs and medical devices — using approved remedies in unapproved ways — has long been a part of medicine. The practice provides public health benefits but also presents some risks.

For the most part, the U.S. Food and Drug Administration allows physicians to prescribe drugs and devices off-label in the same way they are prescribed for their approved uses. The FDA couldn’t require approval for each off-label use because the burden for approval would be so high that few off-label uses would be approved, which would deprive patients of effective treatments for which the drugs weren’t originally intended.

As a result, health care providers have had to make their own decisions about using drugs off-label, often in the face of uncertain evidence.

To address that issue, researchers from the David Geffen School of Medicine at UCLA have proposed a system combining reporting, testing and enforcement regulations, and allowing interim periods of off-label drug prescription. Their recommendations, published in the Duke Law Journal, would give patients more treatment options while providing regulators with evidence of the drugs’ safety and efficacy.

….

The authors’ proposal comprises three elements:

• Improved reporting of off-label use through disclosure of diagnostic codes in reports to the FDA, in detailing data that pharmaceutical companies obtain on physicians’ prescribing habits, and in reports to the FDA and Medicare/Medicaid reimbursement requests. This information, which would omit details that could identify individual patients, could then be shared with academics and pharmaceutical companies for use in research. • Expansion of post-market testing requirements for off-label use of drugs and medical devices. • A tiered labeling system for drugs consisting of “red box” warnings that prohibit certain off-label uses; informed consent from patients receiving prescriptions for off-label use of some drugs that currently carry “black box” warnings, which identify drugs that pose a significant risk of serious or life-threatening adverse effects; and the creation of a new “grey box” warning that blocks Medicare Part D and Medicaid reimbursements by the Centers for Medicare and Medicaid Services.

“The improved reporting, testing and enforcement regulation would work together to produce a more layered range of regulatory responses,” the authors write. “The FDA, armed with better information about the extent of off-label use and adverse effects, would be in a better position to require post-market testing and to discourage off-label use with new types of warnings if manufacturers fail to provide sufficient, timely evidence of safety and efficacy in that particular extrapolation.”

The report can be found at: http://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=3785&context=dlj

 

January 26, 2015 Posted by | Uncategorized | , , , , , , , , , | Leave a comment

Legally poisoned

Legally poisoned

UC Riverside professor outlines risks of daily exposure to toxicants and advocates regulatory changes to protect public health

From a January 24, 2011 Eureka news alert

RIVERSIDE, Calif. – Americans are exposed to hundreds, if not thousands, of suspected toxic substances every day, substances that affect the development and function of the brain, immune system, reproductive organs or hormones. Children are the most vulnerable. But no public health law requires product testing of most chemical compounds before they enter the marketplace.

That must change, UC Riverside professor Carl Cranor argues in a new book, “Legally Poisoned: How the Law Puts Us at Risk from Toxicants” (Harvard University Press, 2011).

The current harm-based or risk-of-harm-based legal structure for regulating exposure to toxic substances is problematic, says Cranor, a professor of philosophy and longtime advocate of reforming U.S. regulatory policies. “Because most substances are subject to post-market regulation, the existing legal structure results in involuntary experiments on citizens. The bodies of the citizenry are invaded and trespassed on by commercial substances, arguably a moral wrong.”

Scientists are finding that every industrial chemical and pesticide produced today is capable of entering our bodies, says Cranor, who has served on science advisory panels for the state of California and on Institute of Medicine and National Academy of Sciences committees. For three decades he has studied U.S. regulatory policy and philosophic issues concerning risks, science and the law, as well as the regulation of carcinogens and developmental toxicants, and protection of susceptible populations from new and existing technologies and toxicants. His research has been supported by the National Science Foundation and University of California Toxic Substances Research and Teaching Program.

Cranor notes that the Centers for Disease Control has identified more than 200 toxicants in the bodies of average Americans, a number that he contends is low only because the CDC has not yet developed protocols to reliably identify other substances.  [See  National Report on Human Exposure to Environmental Chemicals]

“The list is only going to grow over time,” Cranor says.

With the exception of pharmaceuticals and pesticides, the U.S. legal system permits most substances to come in without testing for toxicity, without knowing whether they cause cancer, birth defects, developmental effects, or reproductive effects. Only about 2 percent of 62,000 substances in commerce before 1979 have been reviewed at all for their toxicity by the U.S. Environmental Protection Agency, he says. Of the approximately 50,000 substances introduced since 1979, about 85 percent were allowed to market with no data concerning health effects.

Industrial, often toxic, chemicals are everywhere – bisphenol A used in plastic bottles and that lines cans of food; non-stick cooking surfaces or Gore-Tex material that contains perfluorinated compounds; curtains, baby car seats and TV sets manufactured with brominated flame-retardants; and countless cosmetic ingredients, industrial chemicals, pesticides, and other compounds, all of which enter our bodies and remain briefly or for years.

Chemical contamination is so prevalent, Cranor says, “that it will make future human studies more difficult; there will be no clean controls against which to compare people who are contaminated. We are all contaminated. It’s a question of more or less contamination. So it’s going to be increasingly difficult for the science to detect some of these effects in humans, when they exist.”

The legal process for identifying adverse health effects and removing the responsible substances from the marketplace is extremely slow, he says.

“The only way to reduce toxic contamination is to require testing of products before they come in to commerce,” he says. “If they appear to pose adverse health effects, they should not be permitted, or they should be required to be reformulated so the problems disappear.”

Related Resources

US Centers for Disease Control (especially headings under Environmental Health – Toxic Substances and Your Environment)

US Environmental Protection Agency (especially Learn the Issues)

US National Library of Medicine / US National Institutes of Health Resources, esp

**Toxnet – databases on toxicology, hazardous substances, and environmental health

**ToxTown – Interactive guide to toxic chemicals and environmental health risks. Also in Spanish (ToxTown en español).

January 27, 2011 Posted by | Public Health | , , , , , , | Leave a comment

   

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