See the Video: Rx-360 Testifies Before the US Senate HELP Committee on Security of the Pharmaceutical Supply Chain
Rx-360 testified on 14-September-2011 before the US Senate Committee on Health, Education, Labor and Pensions (HELP) with the following other witnesses:
Deborah Autor, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, FDA
Marcia Crosse, Ph.D, Director, Health Care, Government Accountability Office
Kendra Martello, J.D., PhRMA,
Gordon Johnston, Senior Advisor for Regulatory Sciences, GPhA
Allan Coukell, BScPharm, Director of Medical Programs, Pew Health Group
Martin VanTrieste, R.Ph, Past Chair, Rx360
Click here to go to the Senate HELP Committee website that includes the video from the testimony and all of the witnesses' written testimonies.
In both Rx-360s written and oral testimony, Martin VanTrieste stated: "...we face a complex, global problem that needs a holistic solution requiring industry, regulatory authorities and policymakers working collaboratively to attack the problem. However, it is important that any legislative or regulatory proposals are carefully considered so as to ensure that there are no unintended consequences, such as adding complexity to an already complex system, unintentionally creating drug shortages, and adding significant cost to the health care system. "
The Rx-360 Testimony recommended the following items to consider in any legislation:
- Ingredient suppliers should disclose the actual manufacturing site to the drug product manufacturer: There are many potential links in a global supply chain where a series of brokers and distributors could be involved. If we try to learn from the contaminated glycerin events in Panama we must recognize that one contributing factor is that the drug product manufacturer in Panama had no idea that the glycerin they were purchasing was sourced from China since at least three distributors or brokers did not disclose the location of the manufacturing site. As such the drug product manufacturer did not have the opportunity to audit the ingredient manufacturer and had to depend on the Quality Systems of several foreign intermediaries that did not act in an ethical manner.
- Foreign ingredient manufacturing sites should be registered with the FDA and only those whose products are actually used in the U.S. and pay a nominal fee should be allowed to maintain registration: This will assure that the FDA has an accurate data set to be used for oversight. There are many suppliers who have no intention to distribute product within the U.S. but use an FDA registration to convey a sense of FDA approval to non US-based manufacturers. This behavior only adds misleading data to any FDA database and makes it harder for FDA to achieve their objectives.
- FDA should inspect foreign ingredient manufacturing sites using a risk-based approach and those foreign ingredient manufacturers should pay the cost of FDA inspections: The Food, Drug and Cosmetic Act requires the FDA to inspect domestic manufacturers every two years, but has no such mandate to inspect foreign manufacturers with such frequency. For over 40 years, overseas manufacturers have had unfettered access to the largest biopharmaceutical market in the world with very little regulatory oversight or inspections. This inspection gap between domestic and foreign inspections should be made up quickly, and funded by the sites external to the U.S. According to the recent PEW report, at the current FDA inspection rate, it will take more than 13 years to inspect the sites outside the U.S., and that more than 80% of the drugs consumed in the U.S. are now manufactured outside the U.S.
Today, U.S. manufacturers who are inspected by many foreign regulatory agencies pay for the cost of these inspections. By requiring foreign manufacturers to cover the cost of FDA inspections, this will assure that the FDA will have adequate funding for inspections and experienced investigators. It would also have adequate funding to assure that the appropriate numbers of investigators participate in a foreign inspection and that the length of the inspection is appropriate to provide adequate oversight. Inspection fees should also provide adequate funding so that FDA Investigators are not asked to bear unreasonable hardships when making travel and lodging arrangements. Also, given resource constraints, perhaps FDA and Congress could consider allowing qualified third-party inspectors to inspect these foreign facilities.
- Increased criminal penalties for economically motivated adulteration and counterfeiting: Today, a criminal can make astronomical profits by knowingly engaging in economically motivated adulterating or counterfeiting a biopharmaceutical ingredient or drug product, with little chance of getting arrested and even if they are arrested the criminal penalties are small compared to the crime. FDA and other enforcement authorities should make this a focus for enforcement and criminal penalties should be increased to reflect the gravity of the crime and the life-threatening risks to patients, like those that have been proposed in recent legislative proposals.
Mr. VanTrieste concluded his testimony by thanking the Committee for its examination of this issue. He expressed his appreciation of Senator Bennet's work in this area, and the interest of Chairman Harkin and Ranking Member Enzi in finding solutions to these issues. Rx-360 stands ready to assist the Committee as they continue their work on this important issue.