Congress Preparing Legislation to Improve Pharmaceutical Supply Chain
April 23rd, 2013 // 1:18 pm @ jmpickett
Updated Daily – Read our latest FDA, cGMP Compliance News
The US Senate Health, Education, Labor and Pensions Committee is putting together a draft bill with the goal of bolstering the supply chain for the pharmaceutical industry. This move is coming several months after they came out with a draft discussion on the topic to hopefully reach a consensus.
- April 25 – How to Survive PREDICT – FDA’s New Import Screening Program
- April 29 – Audit Your Lab Like an FDA Auditor – A Roadmap to cGMP Lab Complance
- April 30 – How to Prepare Yourself for 21 CFR Part 11 Inspections
The Congressional effort stems from disagreement over what needs to be done legislatively to make a system that can stop the distribution of drugs that have been counterfeited or adulterated. One of the key problems in the past has been a lack of agreement among pharmaceutical companies, pharmacies and wholesalers about how to approach the problem.
It is those disagreements that stopped the track and trace provision from being in the FDA Safety and Innovation Act that Congress passed in 2012. Track and trace is a way to follow drugs all through the supply chain. Track and trace would require companies to come up with and implement a system that would allow each firm in the supply chain to follow every shipment all through the chain. However, there would be a need for each firm to buy scanners, and an ability for trucks and pharmacies to be able to read the bar codes that are on every bottle that is shipped.
30 states have passed laws that require a pedigree such as the above. But at this time, only the state of California passed a law that mandates a universal requirement and standard for track and trace.
At this point, there is no national system and the law in CA is going into effect in 2015. So pharma is concerned that other states may come up with their own systems and this will cause a complex regulatory minefield that varies by state and this would increase costs, to say the least. And Congress worries that multiple state schemes would not be an improvement to safety and oversight.
According to a Democrat congressman, there have been a high number of recalls and reports of tainted drugs in the last few years, and these drugs are reaching hospitals and the shelves of drugstores. He noted that at this time, we can get more information from a bar code on a bottle of milk than from a bar code on a drug. The idea of the draft legislation is to set up a drug traceability regulatory system that will boost the security and safety of the drug supply chain in the US.
The legislation is still i draft form. At this time, the bill looks like all parties are coming close to an agreement. The document has references to making a type of FDA licensure for wholesalers and logistics providers. The latter does not take actual ownership of product but deals only with shipping the drug products.
Pharma companies would need to serialize almost all drugs, and serial numbers and National Distribution Codes would be given codes. Drugmakers and also repackagers would need to come up with a database that has serial numbers for all drugs they make. there also would be a transaction history, and a transaction statement that each seller has to provide for each buyer along the entire chain.
FDA would do at least 1 pilot program with a full track and trace system. Later on, the agency might come up with a system to replace the original transaction history. This would be a type of pedigree program.
Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:
- April 25 – How to Survive PREDICT – FDA’s New Import Screening Program
- April 29 – Audit Your Lab Like an FDA Auditor – A Roadmap to cGMP Lab Complance
- April 30 – How to Prepare Yourself for 21 CFR Part 11 Inspections
- May 1 – Avoiding Warning Letter Disasters With a Strong cGMP and GCP Quality Agreement
- May 2 – Avoid the CDRH eCopy Confusion – How to Prepare a Compliant eCopy Submission
- May 7 – FDA Recall Chief Update – How to Design a Bulletproof Recall Strategy
- May 15 – FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters
- May 16 – Spend $500K on Compliance or $300 Million on Consent Decree? – Essential cGMP Compliance Tips for Sr. Management
