Get close to the FDA, Australian companies told

Australian companies should start talking to the US Food and Drug Administration (FDA) as early as possible, according to Kendle International's VP of regulatory affairs, Dr Richard Schwen.

At a sell-out AusBiotech seminar in Melbourne on Friday, Schwen gave the audience an overview of the interactions that biotech companies could expect to have with the FDA.

"My suggestion would be that [Australian biotech companies] seek dialogue with the FDA as early as feasible in their program so that they can better confirm that they are on the right R&D track for marketing approval," Schwen told Australian Biotechnology News.

He pointed out that most small biotech companies in the USA were in exactly the same boat as their Australian counterparts, with limited access to FDA-experienced management and a need to build appropriate regulatory frameworks within the company.

According to Schwen, it was critical for companies to build a partnership with the FDA. While the organisation was responsible for enforcing the regulations, they also had a mandate to advance the development of medicines for the benefit of the public, he said.

"The FDA are the police, but they will always be there and you want to have a good relationship with them," he explained. He also noted that it was counter-productive to become confrontational with the agency, and advised seeking to understand the reasons for FDA decisions, rather than outright disagreement.

Talking to the FDA was also a good way to indirectly find out what issues had been raised in competitor's applications, Schwen said. The FDA would often request certain information be obtained or studies completed based on similar problems in other applications.

He described the four formal meetings companies generally held with the FDA -- before the IND (investigational new drug) is filed, at the end of Phase II clinical trials, before the NDA (new drug application) is filed and before final approval -- as opportunities to work with the FDA rather than against them.

The pre-IND meeting, for example, was set up by the FDA specifically to help companies prepare to file their IND, and allowed companies to get feedback from the organisation regarding the completeness of their application.

"You should ask for agreement from the FDA for your proposed plan, rather than asking them what they want you to do," Schwen said.

According to Schwen, most NDA applications had a range of problems and issues to manage.

"There are very few NDAs that don't have major problems or gaps," he noted. But Schwen also warned that companies were obligated to file all of their data with their NDA application, including the bad data.

Schwen said that the FDA would not treat foreign applications any differently to US-based applications, with the exceptions that foreign applications required a local agency to act on the behalf of the company.

He also noted that it was better to initiate discussions with regulatory agencies in different countries in parallel, as differences in the importance attached to particular studies between agencies could cause delays and problems if left until late in the process of approval.

George Mihaly, managing director of Kendle Australia, said that he was astonished by the industry's response to the seminars held by AusBiotech in Brisbane, Sydney and Melbourne this week.

In Brisbane, a full house meant 25 people were turned away from the meeting, with another 40 attending. Sydney had 80 attendees and Melbourne over 120, with attendance capped.