Drugmakers, payers and patient advocates convened at the FDA’s White Oak campus yesterday to present before a panel of regulatory leaders about competition and innovation in the pharmaceutical industry.
The meeting, which was titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access,” opened with FDA commish Scott Gottlieb, who announced that the agency would soon release two documents intended to improve the generic approval process.
The first document is slated to outline a policy that will streamline the abbreviated new drug application review process within the FDA – without lowering approval standards. The agency reportedly said it will clarify in complete response letters what exactly needs to be improved within the application to win approval.
The second note is a guidance document that will highlight common mistakes made in ANDA and tell companies how to avoid them, Gottlieb said.
Gottlieb, who believes that boosting drug development and competition will cause drug prices to drop, added that the FDA needs to deal with companies that game the system to keep generics from reaching the market.
Janet Woodcock, director of the Center for Drug Evaluation and Research, also spoke at the meeting. She provided a brief history of the progress that the center has made in the last 5 years, according to the FDA Law Blog. The CDER has tackled issues involving drug-device combination products and biosimilars.
Patient advocates and representatives of the generic drug industry reportedly brought up several issues at the meeting, including the challenge of “product hopping” – when companies introduce new, reformulated products with small improvements and withdraw the old drug.
But some pointed out that incremental development is a crucial part of the scientific process and that companies need some form of incentive to encourage continuous improvement.
“FDA doesn’t have a direct role in how drugs are priced. But at FDA, we do play a key, if indirect, role in the eventual cost of medicine,” Gottlieb said in prepared remarks. “To the extent that FDA can make sure our own regulatory requirements are efficient, predictable, and science-based, we can also help reduce the time and uncertainty of drug development for both generic and branded drugs — and ultimately impact the cost of these endeavors.”
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