Unapproved Drugs

Speaking Out Against a Public Health Hazard

Numerous professional societies, patient advocacy groups and other organizations have launched educational campaigns adding their voices to the dialogue to express how they feel about the significant risk posed to patients by unapproved drugs. Click on the links below to learn more about their efforts.

Opinion Articles on the Need for Greater Action Against Unapproved Drugs

AOL News Opinion: The Deadly Gap in the Drug Safety Net
Gary A. Puckrein, Ph.D., President & CEO, National Minority Quality Forum

The Huffington Post: Close the FDA Approval Gap
Steven K. Galson, M.D., MPH, Former Director, Center for Drug Evaluation & Research (CDER), FDA

The Huffington Post: Drugs Should Meet 2010 Standards for Drug Safety
John Horton, President, LegitScript

The Daily Caller: Docs in Drug Dispute Must Remember to Put Patient Safety First
Jim Martin, President, 60 Plus Association

Opposing Views: How to Protect Consumers from Dangers of Unapproved Drugs
Gary A. Puckrein, Ph.D., President & CEO, National Minority Quality Forum

KevinMD.com: How HIV sufferers benefit from the FDA’s unapproved drugs initiative
Gary A. Puckrein, Ph.D., President & CEO, National Minority Quality Forum

LegitScript: Maui News Gets it Wrong on Unapproved Drugs
LegitScript Blog

News Coverage of FDA Action Against Unapproved Colchicine

Renal And Urology News: FDA Takes On Unapproved Single-Ingredient Colchicine
Delicia Honen Yard

National Minority Quality Forum: Did You Know

  • “Did You Know” Campaign – National Minority Quality Forum
  • Video: Dr. Puckrein speaks about the dangers of unapproved drugs

Men’s Health Network: Know the Facts

Keep Seniors Safe
The 60 Plus Association, a seniors advocacy group, has launched Keep Seniors Safe, a campaign urging the FDA to enhance its management of unapproved drugs and to mandate that drug manufacturers seek FDA approval under the Agency’s Unapproved Drugs Initiative.

  • Keep Seniors Safe Website
  • 60 Plus Letter to FDA
  • Unapproved drugs: The myths and the facts
  • Seniors’ group raises alarm on unapproved drugs
  • Dr. Woodcock’s response to Jim Martin’s June 3 letter

An audio news report features 60 Plus Chairman Jim Martin discussing the rationale behind his organization’s “Keep Seniors Safe” campaign to educate the public on the hazards of unapproved drugs, and to urge the FDA to fully enforce its unapproved drugs initiative.
A New Advocacy Campaign Urges the FDA to Enhance Its Management of Unapproved Drugs

  • 60 Plus Chairman Jim Martin’s Letter to URL Pharma CEO
  • URL Pharma CEO response to 60 Plus Chairman

LegitScript, the leading Internet pharmacy verification and Internet enforcement service in the United States, recently sent a letter to the CEOs of several large pharmacies and pharmaceutical suppliers affirming the importance of only supplying FDA-approved prescription drugs to patients.

Los Angeles Times

A February 2011 L.A. Times article reports that about 2,000 prescription drugs are being sold without the FDA’s approval.

  • “‘We don’t know what’s in them. We don’t know how they work. We don’t know how they’re made,’ said Michael Levy, director of the FDA’s division of New Drugs and Labeling Compliance.”
  • “The initiative to deal with unapproved drugs has drawn particular support from health groups representing minorities, some of whom have lower incomes and higher rates of uninsurance, which could make them more likely to receive the unapproved medications, which are usually cheaper.”

“FDA struggles to keep unapproved drugs off the market”

Latino Times

FDA Protects Patients from Unapproved Drugs – see story on page 6

  • “There is no reason for a risky, unproven version of a drug to be available when a drug that has proven to be safe and effective is readily available for purchase.”
  • “The FDA has made progress in its efforts to achieve this goal and we hope that the Agency will act quickly to remove unapproved drugs when there are approved alternatives available for patients.”
  • “…it is important to help Latinos become aware of and avoid the potential harms posed by these products.”

National Association of Boards of Pharmacy

  • “Pharmacists are often not aware of the unapproved status of some drugs and have continued to unknowingly dispense unapproved drugs because the labeling does not disclose that they lack FDA approval.”
  • “Manufacturers of unapproved drugs are usually fully aware that their drugs are marketed illegally, yet they continue to circumvent the law and put consumers’ health at risk.”
  • “For all unapproved drugs, the CPG gives highest enforcement priority to the following…Unapproved drugs that directly compete with an approved drug”

National Pharmacy Compliance News; 3Q 2008: “FDA’s Effort to Remove Unapproved Drugs from the Market”; – Article reprinted in State Pharmacy Board Newsletters

CNNHealth.com Report on Unapproved Drugs

A 2007 CNN report highlighted the issue of unapproved drugs and the lack of healthcare professional awareness that some of the drugs they prescribe and dispense have never been approved by the FDA.

  • “I think most doctors, maybe all doctors, assume that if a medication is on the market, it has been approved by the FDA, it must be safe and effective,” American Medical Association President Ron Davis said.
  • “Pharmacists would appear to be no better informed about the status of their drugs. A recent survey showed more than nine out of 10 retail pharmacists didn’t know they could be dispensing drugs not yet approved by the FDA”

“Many Drugs slip through regulatory ‘black hole’”; 9/26/2007

American Pharmacists Association

  • The American Pharmacists Association calls for education and collaboration among health professional organizations, federal agencies, and other stakeholders to ensure that all manufacturer, distributor, and repackager marketed prescription drugs used in patient care have been FDA-approved as safe and effective.
  • APhA supports initiatives aimed at closing regulatory and distribution-system loopholes that facilitate market entry of new prescription drugs products without FDA approval.
  • APhA encourages health professionals to consider FDA approval status of prescription drug products when making decisions about prescribing, dispensing, substitution, purchasing, formulary development, and in the development of pharmacy/medical education programs and drug information compendia.

APhA 2009 Policy Meeting, San Antonio, TX, – “Non-FDA-Approved Drugs and Patient Safety” Policy Adopted April, 2009

MANA National Latina Organization

  • MANA National Latina Organization Press Release Announcing FDA Letter on Unapproved Drugs

New Jersey Consumer Affairs

Group Takes a Stand Against Unapproved Drugs
“No drug or medicine other than a compounded prescription order shall be sold or dispensed in any pharmacy within the State of New Jersey until such drug or medicine has received New Drug Application (NDS), Investigational New Drug Application (INDA) or other Federal Food and Drug Administrative approval, where required.”

New Jersey State Pharmacy Board Regulation – N.J.A.C. 13:39-7.5 (page 39-39)

Providence Health Plans

Insurance Carrier Curbs Reimbursement for Unapproved Drugs

“Over the past several years, there have been dozens of deaths linked to unapproved drugs. …the FDA has taken stronger action against these illegally marketed medications.”

“Providence encourages you to find out if your medications are FDA approved. You can do this by going to the FDA-sponsored resources that list approved drugs.”

“It’s important to note that medications must be FDA-approved to be eligible for benefit payment under your Providence Health Plan prescription drug plan. Your prescription drug coverage is designed to provide a wide selection of safe and effective medications to treat all covered conditions. Our formularies provide you with a list of these options. Members and providers can feel confident that choosing drugs on our formulary have been proven safe and effective, and are covered under the benefit.”

“Is your medication FDA Approved?” – website article, 2010

To read more about associations who have addressed the issue on unapproved drugs, please see the links to the left, which are broken out by professional association.