Budget Crunch, Political Battles Shape Policy Agenda for Year - Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation. - BioPharm International


Budget Crunch, Political Battles Shape Policy Agenda for Year
Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation.

BioPharm International
Volume 25, Issue 1, pp. 11-15


The search by pharmaceutical companies for new products and new markets will further expand global pharmaceutical production, with the relevant opportunities and perils. Rising international sourcing of APIs and excipients will put more pressure on industry to manage production processes to ensure the quality and safety of their products.

A sharp rise in supply problems for vital drugs has led to a focus on drug quality and supply chain problems. The White House unveiled a drug-shortages initiative in October 2011, which supports proposals before Congress to broaden requirements for manufacturers to report to FDA production issues that could lead to supply problems. Policymakers also seek tighter controls on drug imports, better track-and-trace systems, and stiffer penalties for counterfeiting and drug adulteration. FDA officials are instructing pharma companies to police suppliers and distributors more effectively for early detection of quality problems. The regulators also want manufacturers to establish backup plans for dealing with supplier and production snafus that could halt production.

This increased focus on systems for ensuring reliable drug supplies will further intensify efforts by industry, FDA, and other regulatory bodies to promote continuous quality improvement strategies, including adoption of quality standards established by the International Conference on Harmonization (ICH). Regulators are looking to extend these quality assurance policies to include generic drugs and ingredients from other regions.

Efforts to manage manufacturing changes more efficiently will continue, as FDA officials promote more effective product testing and monitoring to reduce variability in drugs and biologics and to prevent "process drift" in manufacturing operations. FDA has proposed modified reporting requirements for certain postapproval manufacturing changes, with an eye to curbing unnecessary oversight. So far, however, manufacturers are disappointed by the limited scope of the regulatory changes.

Drug quality issues will keep up the pressure on FDA to conduct more frequent inspections of manufacturing facilities and to crack down on noncompliant firms, particularly foreign operators exporting products to the US. FDA is looking to expand partnerships and cooperative programs with regulatory counterparts in Europe and other regions as a way to combine inspection resources and avoid redundant oversight. The regulators also are looking to tap into manufacturing data compiled by third parties to free up resources and focus on the most critical compliance issues. Agency officials hope to finalize a number of manufacturing and production policies in the coming year, but recognize that such efforts can be sidelined by new crises and changing priorities.

Manufacturers who experience serious quality control problems face increased attention from federal and state prosecutors, who are looking more at violations of GMPs—in addition to off-label marketing and illegal pricing—as evidence of corporate malfeasance. Pharmaceutical companies have been hit with huge fines and onerous consent decrees for violation of GMPs and other regulations, but the situation may get worse. Government officials are raising the stakes by threatening to impose penalties on individual corporate executives who fail to take action to prevent such violations, and some of the saber-rattling could escalate into real blows.

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