FDA’s Fast-Track Agenda

FDASIA adds another expedited approval path while seeking continuous improvement to manufacturing operations

By Angelo DePalma, Contributing Editor

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“There is tremendous, intense new global scrutiny of marketing and promotional content, clinical data integrity, manufacturing conduct and quality assurances, which had been traditionally taken up only by the U.S, and, to a lesser degree, the U.K.,” says David Resnicoff, an attorney at Miller & Chevalier (Washington, D.C.).

So far, so good. GSK’s transgressions suggested a pattern of disregard for well-established promotional practices that quite naturally spilled across borders. But Resnicoff suggests that officials in emerging markets and companies eager to establish themselves in those markets (GSK’s China operates generated 4% of the firm’s income before the scandal) are playing a game of double-bluff.

 

GOVERNMENT’S OPEN HAND
“Certain emerging markets have woken up to the great sums of money they can make by forcing global companies active within their jurisdictions into paying large settlements over alleged malfeasance. GSK’s conflict with Chinese regulatory authorities was a signal event, likely to be replicated in Russia and Brazil. Executives are wondering when, if ever, it will end.”

FDASIA established regulation as an international endeavor. Robert Young, North American life sciences serialization and track and trace lead at Accenture, suggests that oversight has already expanded beyond supply chain issues. “Pharmaceutical industry regulators face unprecedented pressures in the form of increasingly stringent, globally driven health authority requirements and complex product obligations for initial filings, lifecycle management and ongoing compliance.”

These pressures have intensified the challenge to companies of maintaining authorization for a full portfolio of products 12,000 miles away from headquarters, while continuing to innovate and seek greater efficiencies at home. “Meeting these challenges strains capacity and diverts precious resources from the ultimate goal of bringing new, differentiated products to patients,” Young adds.

Regulatory agencies, moreover, must now confront product expansions into new demographics and geographies, while monitoring the flow of goods and services from these overseas markets into the United States (e.g., FDASIA’s supply chain provisions).

Young believes that current practices for managing pharmacovigilance are “unlikely to be sustainable.” Regulators’ workloads are expanding rapidly, at 10–20% a year, a result of higher regulatory expectations, tougher inspection regimes, business growth and more proactive physician/patient reporting.

INTER-AGENCY COOPERATION
Companies need to determine how the growing flow of granular data can provide value, while regulators have to make sense of it all. The solution, says Young, will be new ways to process and interpret “big data,” much of which will originate overseas. Moreover notions of patient privacy differ dramatically between the U.S./U.K. and developing markets, which will by necessity involve inter-agency cooperation, similar to that encouraged by FDASIA.

“These data concepts are new territory,” Young says. “Companies recognize that they are not data analysis experts and may not want to staff internally to support this. Hosted services will therefore evolve in this area, but even they require skills that integrate back to companies’ supply chain data to create a full end-to-end picture.”

CMC CHANGES
In keeping with the climate of continuous improvement in manufacturing operations, sponsors often file submissions to implement post-approval production changes. FDA categorizes CMC changes as major, moderate and minor. Major changes carry “substantial potential to have an adverse effect on the identity, strength, quality, purity or potency of a drug product.” Major changes require submitting a supplement, called a Prior Approval Supplement (PAS), and FDA approval before distributing products produced as a result of the change.

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