Pharmaceutical & Life Sciences News

2019 Outlook: Drug Competition Stays at Forefront of FDA Agenda

Dec. 18, 2018, 10:46 AM

The FDA will keep charging forward on increasing drug product competition in the new year while also revamping its medical device approval process, FDA leader Scott Gottlieb told Bloomberg Law.

Gottlieb sat down recently with Bloomberg Law to discuss what officials at the Food and Drug Administration have in mind for 2019.

Generic drug approvals have hit record highs since Gottlieb took over as commissioner in May 2017. The thirst for more options, particularly cheaper options, has remained high since President Donald Trump released his drug pricing plan this summer.

Agency heads will continue to push forward on that pricing plan, with particular emphasis on competition and drug abuse reduction. That, along with a regulatory overhaul for how medical devices are approved will keep the Food and Drug Administration busy.

Here’s a breakdown of what Gottlieb says to expect in 2019:

Drug Competition

  • The agency will start reacting to branded biologic developers keeping biosimilar drugmakers out of the market. Biologics are complex drugs made from living cells and are harder to copy than traditional small-molecule products. Biosimilars are cheaper copies of those original biologic products.
  • This past year the FDA started posting the names of smaller-molecule branded companies it suspected of using regulatory hurdles to hinder generic drug development. In 2019 it will also scrutinize branded biologic companies, Gottleib said.
  • Whether U.S. biosimilar companies can use European samples of biologic products to prove their copies are effective and safe will also be a priority for the agency. Gottlieb doesn’t expect Brexit to complicate that discussion.
  • Generic drug development will also get cheaper if the FDA follows through on its plan to cut back on the amount of review cycles a drug company has to go through to get a drug approved.
  • “You don’t see new generic drug companies being formed because I think the barriers to entry have gone up,” Gottlieb said. “And it was never intended that it would cost $10 or $20 million to file a generic drug application.”

Medical Device Overhaul

  • Medical device makers are comparing modern products to potentially outdated technology in the current medical device approval process. That’s a problem highlighted in a recent report by the International Consortium of Investigative Journalists. It found tens of thousands of deaths and millions of injuries reported in the U.S. since 2008 that were linked to medical devices approved by the FDA.
  • Cases where device companies use old standards as a basis for approval of a modern product are creating problems because the old device or standards aren’t “really approximating the performance standards of that new, more modern device,” Gottlieb said.
  • The agency is looking at how it can weed out outdated medical device technology and retire older safety standards that aren’t applicable to today’s products. Gottlieb will focus on determining whether to ditch approval standards that are 5 or 10 years old to start.
  • He also will be looking into whether the agency will need help from Congress to overhaul the approval pipeline.
  • The goal is to make medical devices safer, particularly novel devices that are difficult to compare to products already on the market.
  • Device makers shouldn’t expect approval to take longer than usual, and there will be a grandfathering phase if the FDA gets rid of a particular approval pathway, meaning companies already using that pathway won’t have to start the process over from scratch.


  • Blister packs will remain a priority for the agency. These packs limit the amount of opioids a patient uses after a medical procedure and theoretically will help reduce drug abuse. This will affect immediate-release opioids like Vicodin or Percocet.
  • “We think that if we actually had blister packs available with one- or two-day supply, more doctors would default to those packs, and it would reduce overall exposure,” Gottlieb said.
  • Long-awaited guidance documents for how to prescribe opioids for specific procedures are also on the way, Gottlieb said. Those documents will give much needed clarity to doctors who aren’t sure how to strike the appropriate dosage in post-surgical care.
  • The FDA has provided some guidance already on how drugmakers should label fast-acting opioids and has expanded which opioids should come with medication guides for providers and patients.

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Allison Gatrone at agatrone@bloomberglaw.com

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