Seniors Group Asks All in Drug Distribution Chain to Help Protect Patients from Unapproved Products

60 Plus applauds FDA’s removal of untested colchicine from market, but reminds that more work is needed to protect patient safety

ALEXANDRIA, Va.--(BUSINESS WIRE)-- James L. Martin, chairman of the 60 Plus Association, a seniors advocacy group, applauded the Food and Drug Administration’s (FDA) decision to remove unapproved colchicine products from the market, and called on drug manufacturers, distributors and pharmacies to help the FDA protect patients from unapproved drugs.

“On behalf of 60 Plus, I would like to thank the FDA for calling for the removal of unapproved colchicine from pharmacy shelves. Patients are now safer because of the agency’s actions,” Martin said. “It is important, however, to remember that thousands of unapproved drugs are still available and that all involved in the drug distribution chain must work to protect patients from potential dangers posed by these drugs. That means the FDA must enhance its enforcement of the Unapproved Drugs Initiative by removing the remainder of unapproved drugs when approved versions are available.”

Martin’s comments came in response to actions taken by the FDA on September 30, 2010 to remove unapproved colchicine products from the American drug-marketplace.

Unapproved drugs have never been through FDA’s testing process to help ensure their safety and efficacy. They could pose a significant threat to the health of patients as they do not include safety information regarding proper dosage and regimen, or warnings meant to help patients avoid dangerous drug to drug interactions.

The FDA made the removal of unapproved drugs a priority in 2006 when it announced the “Unapproved Drugs Initiative,” which calls for the removal of unproven drugs from the marketplace.

60 Plus is a non-partisan advocacy group that represents 5.5 million seniors and believes strongly in the need to stop manufacturers, doctors, and pharmacies from distributing unapproved drugs when an approved version is available. For this reason, 60 Plus is currently engaged in the “Keeping Seniors Safe” project, an informational resource for those who are concerned about the dangers of unapproved drug use.

The 60 Plus Association is an 18-year-old nonpartisan organization working for death tax repeal, saving Social Security, affordable prescription drugs, lowering energy costs and other issues featuring a less government, less taxes approach. 60 Plus calls on support from nearly 5.5 million citizen activists. 60 Plus publishes a magazine, SENIOR VOICE, and a Scorecard, bestowing awards on lawmakers of both parties who vote “pro-senior.” 60 Plus has been called, “an increasingly influential senior citizen’s group” and since 1992 “the conservative alternative to the AARP.”


60 Plus Association
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KEYWORDS:   United States  North America  Virginia

INDUSTRY KEYWORDS:   Seniors  Health  Public Policy/Government  Healthcare Reform  Pharmaceutical  Public Policy  White House/Federal Government  FDA  Consumer