Mens Health Policy

You are here: Home » Health Policy » Drug Safety
Friday, 20 Oct 2017

Unapproved Drugs

E-mail Print PDF

Numerous, patient groups continue to monitor the drug pipeline to ensure that we have safe and effective drugs. One important coalition in this effort is the Partnership for Safe Medicines, and coalition of industry, regulatory, and patient organizations. You can learn more about this effort here.

Another important consideration for drug safety is those products that have not been approved by and are not monitored by the Food and Drug Administration (FDA). Addressing this important issue, in 2010 Men’s Health Network launched the "Know the Facts" public education campaign on unapproved drugs.

This highly successful “Know The Facts” campaign raised awareness about the risks associated with prescribing and taking unapproved drugs that have not been subjected to the rigorous Food and Drug Administration’s review process. The campaign included a policy statement, a white paper on unapproved drugs authored by Dr. Salvatore Giorgianni, Pharm.D., and a response mechanism whereby consumers could voice their support for swift enforcement action against unapproved drugs which have not been proven to be safe and effective.

The "Know the Facts" Campaign:

Called 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

Urged health care providers and medical associations to avoid the use of unapproved drugs whenever there are safe, FDA-approved versions available

Called 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

Urged manufacturers of unapproved drugs to do the right thing and seek FDA approval by conducting the necessary studies

The campaign offered helpful information on safety and policy issues related to unapproved drugs.

Read our "Policy Statement on Unapproved Drugs" here. (PDF)


Read the White Paper, "Unapproved Drugs in America," here. (PDF)

Contact Blue Ribbon Advocacy Alliance for further information at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Add comment

Security code Refresh