Men's Health Network Launches Public Education Campaign on Unapproved Drugs

Saturday, April 17, 2010 Education News
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WASHINGTON, April 16 /PRNewswire-USNewswire/ -- Men's Health Network (MHN) announced today it has launched a new public education

initiative aimed at consumers, the healthcare community and policymakers to raise awareness about the risks associated with prescribing and taking unapproved drugs that have not been subjected to the rigorous Food and Drug Administration's (FDA) review
process. The "Know the Facts" campaign includes a policy statement, a white paper on unapproved drugs authored by Dr. Salvatore Giorgianni, Pharm.D., and a response mechanism whereby consumers can voice their support for swift enforcement action against unapproved drugs which have not been proven to be safe and effective.  Unapproved drugs may represent a serious danger to the public's health for one or a combination of the following possible reasons:

  • They lack clinical testing to determine safety for human consumption and whether the drug is effective;
  • They may contain unknown or unregulated ingredients;
  • They lack FDA oversight of manufacturing operations to ensure batch purity, strength and uniformity;
  • They frequently lack proper labeling, which can lead to improper dosing and the inability to predict drug-drug interactions; and finally
  • They lack important postmarket surveillance that can identify potentially life-threatening side effects.

"Patients, health practitioners and policymakers should be fully aware that, because they were introduced prior to existing regulations, several important prescription drug products have NOT gone through critical FDA evaluations for safety and efficacy," said Dr. Salvatore Giorgianni, Pharm.D., of the Belmont University School of Pharmacy and Scientific Advisor to Men's Health Network. "Through the 'Know the Facts' campaign, we hope to shed light on the dangers represented by unapproved drugs, which account for an estimated 72 million prescriptions a year to American consumers.  FDA is working hard to address this issue and we applaud and support this effort.  Protecting access, while protecting quality and safety, is the right thing to do for all Americans."

Specifically, the "Know the Facts" campaign:

  • Calls on FDA to  continue to exercise its enforcement authority by moving quickly to remove unapproved products from the market when a safe, FDA-approved alternative is available
  • Urges health care providers and medical associations to avoid the use of unapproved drugs whenever there are safe, FDA-approved versions available
  • Calls on patients to discuss with their physicians whether unapproved drugs are included as part of their care, to understand the risks and benefits of using unapproved drug therapies, and to seek out alternative treatments wherever possible
  • Urges manufacturers of unapproved drugs to do the right thing and seek FDA approval by conducting the necessary studies

FDA Initiative on Unapproved Drugs

In 2006, FDA instituted a "Compliance Policy Guide," or CPG, which outlined its approach to addressing the problem of medicines that are marketed without FDA approval.  Many of these products were introduced prior to current FDA review standards and are widely used.  The CPG described the FDA's right to enforcement action to stop the manufacture of unapproved drugs due to safety concerns, stating in part that "FDA intends to evaluate on a case-by-case basis whether justification allow continued marketing for some period of time after FDA determines that a product is being marketed illegally."

To access "Know the Facts" campaign materials, including an informative and educational white paper, "Unapproved Drugs in America," please visit Men's Health Network's Policy Center at

About Men's Health Network

Men's Health Network, established in 1992, is a national non-profit organization whose mission is to reach men and their families where they live, work, play, and pray with health prevention messages and tools, screening programs, educational materials, advocacy opportunities, and patient navigation. For more information please visit or follow MHN on Twitter: @MensHlthNetwork

SOURCE Men's Health Network

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