In another case of a medical practitioner stepping outside the secure drug supply chain, a Florida doctor stands accused of purchasing medication on the black market via Internet sites purporting to be in Canada and elsewhere. Howard Skalmberg, Deputy Commissioner for the FDA’s Global Regulatory Operations and Policy, will be the keynote speaker at Interchange 2014 in Washington D.C. At the Interchange, Deputy Commissioner Sklamberg will share what the FDA is trying to do to protect patients from unscrupulous medical practitioners and fraudulent web pharmacies.

Dr. Ona Colasante is facing charges, including money laundering, health care fraud, introduction or delivery of misbranded drugs and introduction or delivery of non-FDA approved drugs. Owner of two medical practices, one in Gainesville and the other in Hawthorne, Dr. Colasante is alleged to have treated patients with black market drugs illegally imported into the United States, according to the Department of Justice (DOJ).

Have you registered for our annual conference on September 18th?

Don’t miss the 2014 Interchange with keynote speaker Howard Sklamberg, FDA’s Deputy Commissioner. Early bird discounted registration is still available!

Click here to register today.

According to the Tampa Tribune, Dr. Colasante allegedly billed Medicare for services she failed to render and used the funds she generated to buy black market medication and medical devices from Internet sites claiming to be in Canada or other countries. Dr. Colasante allegedly imported osteoporosis treatments and birth control devices, reports the Tampa Tribune.

The DOJ reports that Dr. Colasante allegedly treated patients with these black market medications or devices without their knowledge or consent. If convicted of all 210 charges, Dr. Colasante could face 10 years for each of the 204 charges of health care fraud and money laundering, and 3 years each for the FDA violations. She also will face forfeiture of any profits earned during her alleged venture, the DOJ reports.

Deputy Commissioner Howard Sklamberg of the FDA, our keynote speaker for Interchange 2014, testified before Congress on February 27th about counterfeit medication in the United States. In his testimony, Deputy Commissioner Sklamberg explained why pursuing investigations of medical practitioners who step outside the FDA’s secure drug supply chain is so essential to the health and safety of patients:

“Health care practitioners who expose patients to unapproved or counterfeit drugs are risking their patients’ health. Therefore, the Agency is conducting proactive educational outreach to the medical community and other stakeholders to ensure they have an understanding of how to purchase drugs both legally and safely. It is crucial that they understand why they should not circumvent the safeguards that Federal and state authorities have in place to ensure the purchase of safe and effective prescription drugs.”

By S. Imber