• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Drugmakers talk competition & innovation with FDA leaders

July 19, 2017 By Sarah Faulkner

FDADrugmakers, 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.”

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Policy, Regulatory/Compliance, Wall Street Beat

IN CASE YOU MISSED IT

  • FDA approves first targeted infusion therapy for HER2-low breast cancer
  • Abbott, WeightWatchers partner on diabetes care
  • Insulet up on Q2 sales beat, raised full-year guidance
  • Aptar acquires Orbital dry powder inhaler license
  • Tandem sinks on Q2 misses, slashed sales guidance

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS