Fleshing Out FDASIA - Pharmaceutical Executive


Fleshing Out FDASIA

Pharmaceutical Executive

Supply chain security

As the analysts and lawyers continue to pore over the fine print of the legislation, the Monday-morning quarterbacks questioned whether Congress should have taken more time to resolve contentious issues, notably requirements for a national track-and-trace system for prescription drugs. Here, policymakers were stalemated by industry's insistence that tracking apply only to production lots—and not individual vials and bottles, as FDA demanded. Manufacturers consequently still face multiple state tracking requirements, starting with a California law that goes into effect in 2015.

Even so, the final law contains a wealth of provisions designed to help FDA detect and block adulterated medical products. All drug manufacturers and foreign suppliers have to register with FDA using a unique facility identifier. Importers must meet numerous requirements and file registration information electronically. FDA may block imports from manufacturers that deny access to inspectors and may detain —and even destroy—adulterated products at the border, instead of having to send them back to the shipper. Manufacturers have to notify FDA if a drug may be stolen or counterfeited, and intentional adulteration for economic gain carries stiff penalties, including jail time.

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An important change overrides the established, but long unworkable two-year pharma plant inspection requirement and permits FDA to schedule inspections based on risk factors. Another provision promotes drug quality by specifying that good manufacturing requirements involve quality management systems. FDA may share trade secret information with trusted regulatory counterparts, and US law governing drugs and medical products may be applied to extraterritorial violations, such as economically motivated adulteration of products like heparin.

To curb critical drug shortages, the law extends reporting requirements for manufacturers anticipating short supply situations and gives FDA clear leeway to expedite inspections and application reviews to help mitigate or prevent a shortage. The Drug Enforcement Administration has to provide timely approvals or denials of requests to increase quotas of controlled substances when needed to address a drug shortage. There will be an FDA annual report on its success in stopping shortages, along with a drug shortage list that will help patients and providers stay informed about supply problems. And a new HHS task force will examine ways to enhance the federal response to shortages and create a strategic plan to address these problems.

Regulating apps

FDASIA even addresses how FDA may—or may not—regulate medical applications for smartphones and other computer devices, a hot issue for software developers, manufacturers, and health authorities. The final bill stops short of prohibiting FDA from finalizing a draft guidance issued last year that proposed agency regulation of software that links to a device such as an MRI or infusion pump—but not low-risk apps such as calorie counters. Even so, FDA officials are expected to hold off on issuing new guidance until a working group required by FDASIA quickly (in 18 months) develops a strategy for an "appropriate, risk-based regulatory framework" on health IT "that promotes innovation, protects patient safety and avoids regulatory duplication." FDA will consult with the National Coordinator for Health Information Technology and the Federal Communications Commission and include manufacturers, payers, venture capitalists, IT vendors, patients, providers, and others in the working group.

The compromise measure reflects concerns of software and medical device companies that FDA will over-regulate this budding industry, squashing innovation and promising health technology in the process. Some 40,000 medical apps have been developed, some by pharma companies looking to enhance patient use of treatments for diabetes and other medical conditions and to help manage clinical trials. A firm recently sought and gained FDA approval for an app that displays radiological images, and some IT firms support FDA regulation to gain more predictability in market requirements, despite the cost and time of compliance.

With so many provisions, it's not surprising that FDASIA does not please everyone. Some consumer advocates warn that more accelerated approvals may expose patients to unsafe therapies. Infectious disease experts wanted provisions to ensure appropriate use of antibiotics. FDA will consider these and other perspectives in developing a communications plan on risks and benefits of medical products and in assessing the gains provided by new PDUFA V review program for new drugs and biologics.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at


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