More Counterfeit Drugs Pop Up – What to Do?

More Counterfeit Drugs Pop Up – What to Do?

April 30th, 2013 // 12:38 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

Congress is currently mulling over a bill to provide better security to the drug supply, but we are seeing reports of still more counterfeit drugs coming onto the market. The latest is regarding an FDA alert about fake Botox, with the labels on the vials showing they are a foreign variant of Botox. This counterfeit drug is being sold online and by fax to doctors’ offices.

Also, Teva Pharmaceuticals just discovered there are fake types of its generic Priolosec, which is for acid reflux disease. This goes against the idea in Europe that fake drug makers are not as likely to make cheap, fake generics because the profit margin is less.

These incidents show how despite many concerns and legal efforts, there are still many fake drugs getting onto the American market. At this time, there is no system in the US that can effectively stop the introduction of counterfeit drugs into the marketplace. The big reason for this is that there is no agreement between pharma companies, pharmacies and wholesale companies about how to do a track and trace system. This would be a comprehensive way to follow a drug all along the production and marketing path.

Thirty states have laws that require pedigrees. This means they require companies to take measures to show that medicines have been properly made and possessed during manufacture and shipping. But only CA has a mandate for a track and trace program. The CA law will begin in 2015, and the fear is that other states will set up their own separate systems. This would boost costs because the drug maker would have to meet requirements for many states at once.

The House and Senate did introduce some variants of a track and trace system last week into Congress. Both versions have a lot level type system. But the system that could track unit products would not start for a decade at least. The concern is that a system that is unit level would mandate large investments for equipment, including scanners and trucks, and for pharmacies to have to be able to read bar codes on each drug bottle. Some rural pharmacies would not be able to afford this and could go out of business.

Several advocacy groups, such as the Consumers Union and National Consumers League, also wrote to the Senate last week to note that there were shortcomings in the bill. They did not like the focus on only a lot level system, and they think that the Senate bill should not stop state pedigree requirements or allow any exemptions for pharmacies in certain areas. They think that there should be a mandate for total product ID at every stage of the chain.

Pew Trusts also noted that providers of third party logistics support should not be able to be licensed without being reviewed by the feds. They also said that Congress should require that all parties, not only the manufacturer, must investigate any product that is suspect. Wholesalers also should have to give lot numbers to later customers, and pharmacies should have to keep all records for six years.

Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:

 


Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner