The FDA has commissioned consultancy firm Booz Allen Hamilton to conduct an evaluation following the outcry over a recent FDA report showing 65 per cent of the 1231 postmarketing (Phase IV) safety studies that pharma companies had agreed to conduct as a condition of approval of a drug are not being completed, or are still "pending".
19 per cent are considered "ongoing" and 2 per cent are "delayed." Meanwhile, all the drugs in question are still being sold in the market.
An editorial recently published in the JAMA was particularly critical of the FDA's role in monitoring the Phase IV studies of the drugs it approves, stating "It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labelling would also be committed to actively seek evidence to prove itself "wrong" in having authorised a product."
However, Dr Hugo Stephenson, president of Quintiles Strategic Research Services, Quintiles told Outsourcing-Pharma.com that the problem lies not in the fact that the FDA does not want to enforce these commitments, but that under the current law they do not have the power to do so.
"There is currently no penalty that the FDA can impose for drug companies that don't complete these trials. The best they can do is impair any future drug approvals the company may want," said Stephenson.
Discussing the possible outcomes of the evaluation, Dr Stephenson believes that the Booz Allen Hamilton recommendation will simply be to petition government legislators to allow the FDA to impose financial penalties to those companies not complying within a reasonable time.
"However, if we look at the serious issues, this doesn't address the heart of the problem," he said.
"The real problem lies in the fact that the FDA are often unrealistic with the comitment studies that they impose on drug companies in the first place. They often ask for a very academic study and don't take into account the practicalities of the trial design or the logistics of conducting the trial," Stephenson said.
This is because the FDA wants to be seen as independent and uses an advisory board panel to decide the design of the Phase IV trials, but while the people who sit on the panel have scientific experience, they don't necessarily have a deep understanding of the practicalities in the design and execution of running clinincal trials.
"It is not that drug companies don't want to complete the Phase IV trials, but that they often find it difficult and impractical to do so under the conditions set by the FDA," Stephenson said.
The regulatory environment in the US is in stark contrast to the situation in the Europe, where the European Agency for the Evaluation of Medicinal Products (EMEA) is a lot more open to dialogue with drug companies to work out a postmarketing agreement that is a lot less fiddly and rigid in design and therefore more realistic.
Stephenson believes that if the FDA are serious about tackling this problem of Phase IV backlog, they should consider taking a more European "open dialogue approach."
Stephenson also believes that the FDA should be encouraging drug companies to be more proactive in appraching them with a trial design they think is reasonable, and then before any agreement is made, allowing a faseability planning period of 1-2 months to be undertaken before any agreement is finalised.
"This type of open dialogue environment leads to a lot better success rate in completion of Phase IV studies," said Stephenson.
"Anecdotally, 70 per cent of postmarketing commitment studies Quintiles are involved with in Europe complete on time and 90 per cent complete within a reasonable period, where as the opposite is true in the US."
The results of the evaluation will be available in 12-months time. Either way, the FDA's new Phase IV focus signals good news for clinical research organisations, who can expect a business boost.