SECURING SUPPLIES; AVOIDING SHORTAGES
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
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.