Tuesday, November 12, 2013

Rumor Mill: Compounding Reform on the Rocks

Rumors abound that comprehensive compounding reform may be on the rocks. While S.959 bill looks to pass the Senate, it will die in the house (HR 3204), according to some sources familiar with the matter. Although the 64 deaths related to New England Compound Center was tragic, it is not a big enough problem for congressional action to expand government oversight given the disaster of the Obamacare rollout. The House is not going to support increased big government, especially when the President has a 41% approval rating.

This may or may not stop FDA from going after regulation of the compounding pharmacy space. However, Congress would have to allocate funds to do so....

More as it becomes available....


  1. RE: H.R. 3204 (Title II):

    We have written to over 73 national media outlets, including print, television and internet, and 28 media sources in your district, to make them aware of the damaging aspects of Title II of Drug Quality and Security Act (DQSA), H.R. 3204. They should be aware of how the Bill will greatly weaken prescription drug security when compared with many other countries. You may be asked to explain if you support the Bill due to Title II.

    The Senator should know that given the history of drug counterfeiting it is very likely there will be a highly publicized drug counterfeiting issue before the next congressional elections. Last fall counterfeit cancer medication meant that cancer patients were not receiving active medication. In the past, patients were killed when heparin was counterfeited, children killed when cough syrup contained the main ingredient of antifreeze, etc.

    Senators who approve of the nicely titled Drug Quality and Security Act (DQSA), H.R. 3204, will likely have to explain Title II of the Bill and why they allowed Big Pharma and Drug Wholesalers to get away with weak controls of prescription drug trade. Try explaining that to the parents of a child harmed by counterfeiting. Someone in the media will likely point out how weak the US drug controls are when compared with other countries.

    While Mr. Reid praises Title I of the Bill to control compounding he completely ignores how damaging Title II is to assuring the safety and authenticity of the US prescription drug trade. This is likely due to the extensive lobby effort to slip Title II of the Bill through by including something many wanted in the form of Title I of the Bill.

    It is much harder to defend Title II because many other countries require prescription drugs to be individually serialized and each sale of the drug to be certified and tracked. If H.R.3204 is passed the US will delay implementation of drug tracking by 10-years. The US drug supply tracking controls will be weaker than Turkey, China, Europe and several other countries. Why should the US citizens tolerate this or compromise? This should be part of the debate.

    1. Another "read it after you pass it"

      While senators praise greater controls for drug compounding they forget that big pharma and wholesalers are getting their way and blocking drug tracking for a decade. Other countries serialize and track drugs now and many others will in the next few years. The same protections for US citizens will be years behind much of the world, allowing counterfeiters to focus on the US.

      We implore the senators to read Title II of H.R.3204 before passing it. Can they really afford to be explaining the negative outcome of another healthcare related Bill when they seek reelection?

      The compounding controls, which many senators praise, were added as the first title of a Bill with two titles. The second title is intended to benefit big drug wholesalers and manufacturers by delaying drug tracking for anti-counterfeiting. Without a method to measure and detect counterfeiting no one knows the real problem. Many other countries require drug tracking to protect patients. Title II of H.R 3204 was the failed H.R. 1919 from earlier in the year. Title II has the right buzzwords but the timing is what the senators are missing.

      The negative aspects of Title II far outweigh the benefits of Title I. Today we may see senators tricked into passing a Bill that they will be criticized for in the future.

      Now the senators praise the PDSA members as supports of the Bill. PDSA just wants to avoid protects that cost money, yet other countries require the protections. The Prescription Drug Security Alliance (PDSA) was formed by a consortium of drug companies and wholesalers seeking to overturn a California law scheduled to require drug tracking beginning in 2015. They funded Baker Daniels to lobby for federal law to benefit the PDSA members. Others back the law for the controls on compounding and are not focused on drug tracking.

      While the notion of a single federal law for drug tracking is appealing the delayed timing in the Bill disenfranchises US patients by preventing tracking for 10 years while the FDA decides how to track drugs, something many countries already do.

      QUESTIONS to ask the Senator:

      WHY WAIT 10 YEARS? The California law has been in place since 2007, most pharmacy groups and drug manufacturers signed on to the phased implementation in 2008 (reference letter from CA State Senator Ridley-Thomas) and many manufacturers already have started to serialize.

      WHY PLACE THE UNITED STATES BEHIND CHINA, TURKEY AND EUROPE for drug safety and traceability? Drug companies engaged in global trade will have to serialize and track their products in many other countries, but not the US.

      WHAT WILL YOU SAY WHEN SOMEONE IS HARMED BY A COUNTERFEIT THAT WOULD HAVE BEEN DETECTED under the state law or a more realistic federal timeline?

      WHY NOT SPLIT OUT THE COMPOUNDING AND TRACKING? Controls of compounding are needed, but slipping in weak tracking requirements for the rest of the pharmaceutical industry can only hurt US patients.

      CONSIDER WHO IS ASKING FOR THE WEAK TRACKING? Pharmacy groups wish to avoid rules that would make them actually take an action to ensure the drugs they dispense are authentic. Drug manufacturers do not wish to measure counterfeiting and expose a problem. They also want to save money, but other industries serialize and track products to protect their brand name and investment in consumer confidence. Drug wholesalers don’t want it because it could expose how easy it is to inject counterfeits into an industry where drugs are bought and sold over and over again, changing hands many times.


      Please – do not vote for H.R.3204 due to Title II. Separate the Bill into two and debate them each.