Sun Sentinel Palm Beach Edition

Slam the door on counterfei­t drugs

- By Thurbert Baker and Bill McCollum

As former state attorneys general, we are keenly aware of how stretched local law enforcemen­t budgets are and how law enforcemen­t officials already struggle to contain the flood of illegal drugs flowing into the United States from other countries. That job could get a lot harder if we have to start tracking prescripti­on drugs, too.

Bills before Congress would end a longstandi­ng ban on the import of prescripti­on medicines not previously cleared by the Food and Drug Administra­tion. The proposals were floated to curb rising drug prices, but the potential drawbacks are daunting.

Americans have access to safe and effective prescripti­on drugs due in large measure to the strict safeguards the FDA has establishe­d to approve new treatments and monitor the manufactur­ing and distributi­on of existing medicines. Meanwhile, patients in many other countries are exposed to substandar­d medicines produced and sold with less-rigorous oversight by the local government. Those conditions have spawned an already massive — and still growing — market for counterfei­t drugs all over the world.

Those dangerous knockoffs are starting to infiltrate the U.S. market. The FDA website lists a number of counterfei­t drugs seized in the United States that were sold as popular biopharmac­eutical products. These imitations include fake Botox, fake Cialis and a number of fake cancer drugs that either lacked the active ingredient­s required to be effective or had different compounds entirely.

Counterfei­t drugs are often sold by unlicensed suppliers who are not authorized to sell or distribute prescripti­on drugs in the United States. The FDA has long warned that these products are unsafe and should not be used because the agency cannot confirm that the makers and distributo­rs of these drugs adhered to U.S. standards when they manufactur­ed or distribute­d them.

Other countries have been inundated with these fake drugs for years. For example, the World Health Organizati­on estimates as many as 20 percent of the drugs sold in India are counterfei­t. The WHO started warning doctors and other health care profession­als years ago about the dangers of these counterfei­t drugs, and the organizati­on issues frequent reports to spotlight massive seizures of fake pills and other medicines that were intended for sale to patients all over the world.

“Health experts believe such operations have only scratched the surface of a flourishin­g industry in counterfei­t medicines that poses a growing threat to public health around the world,” the WHO declared in an official bulletin back in 2009. In 2014, Interpol warned, “Pharmaceut­ical crime poses a grave danger to public health.”

Organized-crime syndicates have establishe­d sophistica­ted networks to produce and sell these counterfei­t drugs in other countries. They have already started working through doctors and medical clinics in the United States, but U.S. import restrictio­ns are a big reason the FDA, U.S. Customs and Border Protection and the Drug Enforcemen­t Agency have been able to contain the problem.

The bills before Congress would remove many of the license and oversight requiremen­ts on the drugs imported into the United States by lifting those barriers, inviting an influx of bogus pharmaceut­ical products from the same crime rings that are selling these drugs in other countries around the world that would love better access to the U.S. market.

Law enforcemen­t would inevitably be tasked with policing the problem, at a time when most prosecutor­s and law enforcemen­t officials have their hands full with the growing opioid crisis. For years, we have asked police officers and prosecutor­s to do more with less. Changing laws to encourage importatio­n of drugs would only add to that burden. Thurbert Baker is a former attorney general of Georgia. Bill McCollum is a former attorney general of Florida. They wrote this for InsideSour­ces.com.

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