Pharmaceutical Commerce - July/August 2011 - (Page 7)

OpEd After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs* Industry and FDA can—and must—do more to protect global pharmaceutical supply chains Alan Coukell, Pew Prescription Project Ensure meaningful oversight and quality management of globalized pharmaceutical manufacturing • Require 21st-century quality systems to protect drug safety through statute and regulation • Strengthen industry oversight of contract manufacturers and suppliers • Enhance documentation and transparency of upstream manufacturing supply chains through legal requirements • Improve testing standards Pharmaceutical manufacturers and distributors work together in a robust system to deliver high-quality products, but drug manufacturing and dist r ibution have become increasingly complex in recent years. Prescription and over-the-counter (OTC) medications originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers and distributors. The number of drug products made outside of the United States doubled from 2001 to 2008, according to FDA estimates. The FDA estimates that up to 40 percent of finished drugs used by U.S. patients is manufactured abroad, and 80 percent of active ingredients and bulk chemicals used in U.S. drugs comes from foreign countries. Increasingly, the United States relies on drug manufacturing in developing countries— mainly China and India. Globalization, increased outsourcing of manufacturing, the complexity of pharmaceutical distribution and the existence of criminal actors *This article is excerpted from the Pew Prescription Project report of this name; the full report is available at www.prescriptionproject.org. willing to capitalize on supply chain weaknesses has created the potential for counterfeit or substandard medicines to enter the system and reach patients … This report concludes that more can— and must—be done to ensure the safety of “upstream” pharmaceutical manufacturing, to provide the FDA with essential authorities and resources to exercise effective oversight and to improve the security of “downstream” pharmaceutical distribution. In a world where drug manufacturing is increasingly outsourced and offshored, robust supply chain management is critical. Pharmaceutical companies have the ultimate responsibility for drug quality and safety, but some companies may not be adequately verifying the quality of their suppliers. … It is essential that manufacturers look beyond current manufacturing quality standards (known as good manufacturing practices, or GMPs) in their own facilities to ensure appropriate supplier qualification, through risk-based assessments, quality agreements and physical audits, where appropriate. … Improved oversight of foreign manufacturing is essential and will require increased resources for the FDA, some of which could be obtained through industry fees. In addition, the agency will have to make additional use of third-party inspections, including those by other regulators and, potentially, private entities. The FDA also requires certain new authorities to enable effective oversight and must more effectively use its existing authorities and resources. The agency should have the power to mandate recalls, subpoena witnesses and documents and destroy at the border any products that present public safety risks. In the long term, ameliorating risks to the U.S. and global drug supply requires international cooperation, harmonization of standards and steps to improve the capacity of regulatory bodies in the developing countries where manufacturing increasingly takes place. The movement of finished drugs from manufacturer to the consumer is also a complex process involving many intermediate players. The past decade has seen several instances of adulterated and counterfeit drugs infiltrating U.S. distribution. … Manufacturers, wholesalers and pharmacies have taken steps to secure the distribution pipeline, but risks persist. No national system exists for tracing the provenance of finished drugs as they are bought and sold. Requirements for drug pedigrees and wholesaler licensure vary widely among states. Drug distribution tracking and regulation must be improved; methods of documenting the movement of drugs at the individual package level have been attracting support, and a universal system should be implemented. … This report makes the following key policy recommendations: Eliminate barriers to FDA oversight • Increase FDA oversight of overseas manufacturing • Ensure adequate FDA resources • Improve the FDA’s infrastructure and tracking systems • Strengthen oversight of drugs and bulk drug substances at import • Empower the FDA with regulatory authorities it needs to fulfill its mission • Strengthen the FDA’s enforcement ability through stronger penalties and clearer accountability for industry • Improve FDA access to information from other regulatory bodies and industry Secure pharmaceutical distribution • Improve drug distribution security through a federal serialization and verification system • Strengthen wholesaler regulation and oversight. ABOUT THE AUTHOR: Alan Coukell is director of medical programs, Pew Health Group (Washington, DC), of which the Pew Prescription Project is a part. FDA: Pathway to Global Product Safety and Quality* Margaret Hamburg, FDA Commissioner We live in a nation that increasingly relies on other countries to produce the food, drugs, cosmetics, and devices we use in our daily lives. … Half of all medical devices used in this country are imported, while 80 percent of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere. At the center of this global bazaar is the FDA. Today, nearly 25 cents of every dollar *Excerpted from “Pathway to Global Product Safety and Quality,” FDA, July 7, 2011, available at www.fda.gov. spent by Americans are on products regulated by the agency. FDA-regulated products account for about 10% of all imports into the U.S., arriving from more than 300,000 facilities in 150 different countries. The growth in imports has been rapid— and promises to accelerate. Just a decade ago, 6 million shipments of FDA-regulated goods passed through the nation’s 300 ports of entry. This year the number will quadruple to 24 million shipments. Each year over the last seven years, food imports have grown by an average of 10%, while imports of pharmaceutical products have increased at nearly 13% and devices have grown at over 10%. Between 2007 and 2015, it is estimated that imports of FDA-regulated products will triple, corresponding to a 15% growth rate. . . . This rapidly changing environment, and a desire to move from a posture of intercepting harmful products to anticipating and preventing the arrival of such goods, has prompted FDA leadership to develop this “Pathway to Global Product Safety and Quality.” Throughout history, FDA’s primary tools for product safety and quality have been ‘FDA DOES NOT—NOR WILL IT—HAVE THE RESOURCES TO ADEQUATELY KEEP PACE WITH THE PRESSURES OF GLOBALIZATION.’ inspections at production facilities and ports of entry. Over time the agency has developed additional methods for protecting the public, including laboratory sample analyses for select product categories (e.g., foods) and product safety reporting systems. Yet the safety of America’s food and medical products remains under serious threat. Imported vegetable protein contaminated with melamine has sickened and killed American pets, and milk tainted with melamine killed and injured children in China. Contaminated heparin, diverted and counterfeit glucose monitor test strips, glycerin contaminated with diethylene glycol (DEG), and low quality titanium destined for medical implants have all raised public health concerns…. In response to increasing globalization, FDA has expanded its capabilities and regulatory authority. The PREDICT system, for instance, uses novel data analytics from the entire life cycle of a product to better identify and target high-risk products before they enter the country. Armed with better intelligence, FDA regulators can both speed continued on page 34> July | August 2011 7 www.PharmaceuticalCommerce.com http://www.prescriptionproject.org http://www.fda.gov http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011
Contents
Op-Ed
Top News
Business/Finance
Brand Communications
Supply Chain/Logistics
Manufacturing & Packaging
Legal/Regulatory
Information Technology
PDMA Exhibitors
Meetings and Editorial Index

Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover1)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover2)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page 3)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 4)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 5)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 6)
Pharmaceutical Commerce - July/August 2011 - Op-Ed (Page 7)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 8)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 9)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 10)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 11)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 12)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 13)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 14)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 15)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 16)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 17)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 18)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 19)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 20)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 21)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 22)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 23)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 24)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 25)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 26)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 27)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 28)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 29)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 30)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 31)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 32)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 33)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 34)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page 35)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page Cover4)
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