The FDA requires a new regulatory model to confront issues presented by globalization, which will include reliance on foreign regulators, according to agency Chief Medical Officer Janet Woodcock.

"The global environment is very challenging and I believe it's going to require whole new regulatory paradigms, whereby we collaborate with other regulators around the world," she said April 12 at Food and Drug Law Institute's annual conference in Bethesda, Md.

Woodcock acknowledged that such collaboration with international regulators may not be well received in the U.S., but said that it will be necessary for the agency to rely to an extent on the findings of other regulators.

"We can't be everywhere, we can't even be everywhere we need to be really in the U.S. right now," she said. "We certainly are not going to be all around the globe and every factory, nor do we speak the language nor do we understand the local criminals and so forth. So we have a whole lot of challenges to dealing with the global environment."

In recent years, pharmaceutical companies have been offshoring and outsourcing research and development and manufacturing operations to Asia and particularly India, mainly in an effort to reduce costs (Also see "India Ready For Chemistry Outsourcing, Wyeth Says; Biology Remains In West" - Pink Sheet, 2 October, 2006., p. 14).

"We're seeing an increased number of pharmaceuticals manufactured in India and China and a number of other up and coming places around the world, and manufacture of pharmaceutical ingredients, bulk ingredients, APIs," she said.

"I think this trend is going to continue and probably, manufacture of pharmaceuticals in the United States is going to continue to dwindle," she said.

Woodcock said that the agency, which was developed to regulate a domestic industry, is not able to address the increasingly complex problems posed by globalization.

While FDA has wrestled with the issue of prescription drug importation for some time, recent headlines have illustrated the agency's struggles to oversee legal imports of other types of products, such as food.

"In the 1990s there was an exponential rise in imports of all kinds, and these have not stopped; there's no sign of this leveling off," she said. "And so we have an agency that's focused on domestic regulation suddenly - it seemed like, although it had been building over time - faced with this flood of imports."

The proliferation of importation, coupled with the innovations in business, such as more efficient supply chain management and distribution management, has led to a situation where products are not only brought into the country from throughout the world, but they are distributed rapidly throughout the U.S., she explained.

"They are in the hands of consumers immediately in all kinds of states, or pet food owners, or whatever, okay, and suddenly the distribution, the impact of any change or any problem can be completely magnified by these innovations and how products suddenly just penetrate into the market and are shipped everywhere," she said.

"This again poses extreme problems for an agency that was really conceived of overseeing domestic establishments, pharmaceutical establishments, so FDA's regulatory scheme again, in my opinion, has not really been set up to deal with this," Woodcock said.

FDA is also faced with the challenge of extrapolating data from clinical trials conducted overseas, Woodcock said.

"Clinical trials are going overseas, period," she said. "The industry's taking their trials elsewhere because it's too expensive to do the trials in the United States, so it's driven by costs."

"We have to figure out how to deal with integrity data that come from trials in other countries, not to mention we have scientific problems intensifying, it's intensified in recent years, of extrapolating findings from one population, maybe a Third World-type of population, to our population and making sure the drug could still be safe and effective ... under the conditions of the United States," Woodcock said.

"Our current system for ensuring the integrity of U.S. clinical trials has been strained for years, and we see controversies intermittently now about our program, our inspectional programs over clinical trials," she said.

Woodcock noted that the quality of clinical trials has improved over the past 20 to 30 years. "Maybe that's self-centered of the FDA, but we believe that it's because we've been out there with our standards and our inspectors.... Now we're talking about Eastern Europe, we're talking about China...and so the model that we have for regulating, that we've been operating under, doesn't fit really well."

CDER Director Steve Galson echoed Woodcock's comments during a session at the FDLI conference the following day.

FDA is very interested in investigating a new paradigm, Galson said. "It raises important international harmonization issues; we are invested in working with [the International Conference on Harmonization] and some other international harmonization efforts ... answering questions like would the agency accept an inspection that the Indian regulators would do and not actually go to all the sites."

"We are very gingerly stepping and putting our toe in that water, but as you can imagine there are some very, very complex questions of data acceptance."

However, problems arise from accepting another country's data because their regulators "never do exactly what we want them to do," Galson said.

"Every country has its own concept of how to do an inspection, how to audit a clinical trial and this is why the harmonization effort that we have been engaged in ICH has gone slowly. They've moved forward, but they take a lot of investment in time, and industry folks are involved with them as well."

The next meeting of the ICH steering committee, which brings together regulators from the U.S., Europe and Japan, will be held in Brussels from May 5-10.

Galson acknowledged challenges the agency is having adapting to globalization. Specifically, it is having a difficult time finding staff willing to go overseas to conduct site inspections, Galson said.

"It's challenging to find experts who want to go to these countries for weeks at a time and it is expensive to send them there, so we need to and we are working on recruiting new people into the center that are interested in doing this kind of work," he said.

"We are working on bringing people in who like to travel, who like to go to India and China and Eastern Europe, and we are out there inspecting these facilities, but ... we need to have more staff."

- Kathryn Phelps

This article is reprinted from "The Pink Sheet," April 30, 2007

FDA Needs New Regulatory Model In Face Of Globalization, Woodcock Says

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