SEPTEMBER 28, 2013 BY PROTECT MY COMPOUNDS
September 27, 2013
A bipartisan, bicameral agreement on compounding has been linked to the track-and-trace bill, known as the “Drug Quality and Security Act” (HR 3204). Leaders from the House Energy & Commerce Committee and Senate Health, Education, Labor & Pensions Committee made the announcement September 25, and released bill language late that night. Revisions to the bill were made the following day. Proponents in the House are trying to pass the bill under “suspension of the rules”, meaning they need two-thirds of the House to support the track and trace/compounding compromise. We expect this could happen as soon as tomorrow, Saturday September 28.
In conversations with key legislators, PCCA was able to get clarification in the bill which allows compounding pharmacies to elect to become “outsourcing facilities” on a voluntary basis. This is an important change as the first draft of the bill was ambiguous on this point. With the voluntary election provision, the bill paints a clear picture as to why a pharmacy may elect to become an outsourcing facility and, more importantly, shows that the FDA cannot force a pharmacy to become an outsourcing facility because of some arbitrary rule the FDA would feel it could enforce.
There are some additional improvements made to this bill over the Senate Bill 959. HR 3204 does not provide exemptions for certain types of pharmacy practice nor does it require pharmacies practicing under 503(A) to report their compound activities to the FDA when compounding for drug shortages. PCCA would have hoped for additional revisions to 503(A) to modernize a fifteen year old piece of legislation to reflect the current state of pharmacy compounding. If the current legislation is signed into law, we will continue discussions with our legislators about this issue.
After carefully reviewing the legislative options, we believe the bill could still have unintended consequences, however, we also believe opposing or delaying the bill would give other interests the opportunity to negatively influence the bill even further. Therefore, PCCA has decided to be neutral regarding the “Drug Quality and Security Act”.
PCCA is committed to remaining an active participant in legislative issues and continue to represent our members and their patients to ensure access to compounded medications.
Sincerely,
Dave Sparks
CEO
PCCA
CEO
PCCA
2 comments:
Unprotecting the US public from drug counterfeits
This week the US Senate will consider H.R.3204. The bill is a combination of the widely desired controls for compounding organizations following last fall’s meningitis issue, with drug tracking that will block states from enacting drug tracking controls and delays drug tracking at the federal level by a decade. SEE QUESTIONS TO SENATORS BELOW.
THE PROBLEM: The drug tracking requirements will place the US years behind China, Turkey, Europe, Argentina, South Korea and other countries with respect to tracking and authenticating drugs. It will block a California state law that will begin a 3 year phased implementation in 2015 and requires drug companies to serialize each saleable item and provide an electronic certificate to document each trade from manufacturer to pharmacy. The countries above require or have emerging laws to serialize each drug product and report trade to a government database for authenticity.
The weak tracking provisions in H.R. 3204 came from H.R. 1919, passed by the House earlier this year but not passed by the Senate. Spurred on by the Pharmaceutical Distribution Security Alliance (PDSA), a consortium of pharmacy groups and pharmaceutical manufacturers seeking to avoid having to track and authenticate drugs in the US. If there is no item level tracking we leave the door open to counterfeiting, limit investigation by not providing a certification of the item’s trade, and prevent anyone from knowing the true extent of counterfeiting in the US.
The bill was passed by the House on Saturday under “suspension of rules” and a voice vote by a few Representatives.
I suspect most Representatives and Senators believe H.R. 3204 is worthwhile because of the compounding controls and may not understand how the tracking aspects of the Bill will greatly weaken the US drug supply chain.
The Bill includes provisions for tracking drugs using their packaging LOT number. Thousands of items in a LOT contain the same number. Using only LOT traceability easily allows counterfeit copies to enter the supply chain from unscrupulous “authorized” and registered distributors. The distributors may purchase a small quantity of items tracked only by LOT number and produce thousands of counterfeit copies. They will have a record of a purchase and the future recipients will never know which items are legitimate or were produced as counterfeits. Counterfeits can simply be inefficacious or even contain harmful or poison ingredients. Read about this and other techniques in the book Dangerous Doses.
Imagine your child is consuming medication that contains poisons and you found out the trade was less controlled than automobile parts, many electronic parts or cell phones. Reference past counterfeiting of Avastin, Heparin, Cough Syrup containing antifreeze and more. This Bill makes that much more of a reality.
I FEAR THAT THE SENATORS VOTING ON THE BILL WILL BE UNFAIRLY CRITICIZED IN THE FUTURE WHEN THE PUBLIC LEARNS THEY VOTED TO WEAKEN THE US DRUG SUPPLY CHAIN FOLLOWING A COUNTERFEITING EVENT. Critics will point out how other countries are controlling their drug supply chain and how weak the US model is following the enactment of H.R. 3204.
IF NO FEDERAL BILL IS PASSED WE ARE BETTER OFF because a 2007 CA state law will compel drug companies to control their supply chain beginning 2015. The CA law includes requirements for drug manufacturers to serialize each saleable drug item and related shipping cases. It further requires an electronic tracking document (electronic pedigree or e-pedigree) with a digital signature to certify each trade. Counterfeit items would not have a corresponding tracking document and recipients would not accept goods without it because they could not sell it further.
The CA law has become a de facto federal requirement because leading wholesalers require all products to meet the CA law. This is because they do not know which of the products will be sold to that state. This means that without federal preemption we would begin to see serialized drugs with certification of their trade in 2015.
H.R. 3204 delays real tracking for 10 years. It adds serialization in 4 years but does not require anything to be done with the serial numbers until 2023. A response on May 9, 2012 to Senator Tom Harkin from Stanley Weisser, President, California State Board of Pharmacy pointed out key requirements for tracking drugs. Most are missing or greatly delayed in the current federal Bill.
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 NOT BUILD ON THE STATE LAW? The state law referenced above has been debated since before 2007, there are numerous commercial off-the-shelf (COTS) solutions to fulfill the need and many leading drug companies are already preparing for the state law’s 2015 start date.
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.
WHO IS AN ADVOCATE FOR THE CONSUMER? WHO PROTECTS YOUR CHILD’S INTERESTS?
This is a bad law while it contains the very weak drug tracking provisions. Please help communicate the issue and make those who may be harmed know about the issue.
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