FDA Targets Drugmakers Accused of Blocking Generics

FDA officials are publicizing information on brand name drugmakers that use what government officials call “gaming tactics” to block cheaper generic versions.¹ The FDA’s new web page names the makers of more than 50 brand name drugs that are suspected of blocking the entry of generics.²

The agency also lists inquiries it has received from generic drugmakers requesting the FDA’s help in getting access to brand name drugs, although not all complaints have been verified.²

“No patients should be priced out of medicines they need to support their health,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “As stressed by the president and Secretary [of Health & Human Services Alex] Azar last week, one of the administration’s highest priorities is advancing policies that increase competition as a way to help make drugs more affordable and improve access. There isn’t one single action that’s going to solve this issue. We will achieve these public health goals through the coordinated effort of different federal agencies working in partnership with industry and other stakeholders.¹

“At the FDA, we’re taking steps across a broad range of areas to improve new and generic drug competition as a way to improve access and affordability. Among these efforts, we’re especially focused on addressing tactics we sometimes hear of branded companies pursuing as a way to forestall expected generic entry,” Gottlieb added.¹

“[Today], we’re making public a list of companies that have potentially been blocking access to the samples of their branded products,” he said. “We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval.”¹

On May 11, President Donald J. Trump called for “tougher negotiation, more competition, and much lower prices at the pharmacy counter” in a statement on lowering drug prices.³ The statement, which was the subject of a panel discussion at the Asembia Specialty Pharmacy Summit 2018 in May, focused largely on bringing “drug prices under control.”

Trump pointed to the reformation of the Drug Pricing Program for safety net hospitals as one step in that direction. The administration has also acted to remove barriers to generic drug development and market entry to spur competition, he said.

Separately, House Speaker Paul Ryan (R-WI) said on May 17 that a compromise is being worked out on a controversial bill aimed at lowering drug prices, the Hill reported.⁴ The bill seeks to crack down on delay tactics that drug companies use to slow the pace of cheaper generic drugs hitting the market, according to the article.

The bill has been stalled for months because of an intense lobby- ing campaign against it from drug companies, the Hill reported.

References

• Statement from FDA Commissioner Scott Gottlieb, MD, on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition [news release]. Silver Spring, MD: FDA; May 17, 2018. www.fda. gov/NewsEvents/Newsroom/PressAnnouncements/ucm607930.htm. Accessed May 23, 2018.
• Reference listed drug (RLD) access inquiries. FDA website. www.fda.gov/ Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm607738. htm. Updated May 17, 2018. Accessed May 23, 2018.
• Hall C. President Trump urges more competition to lower drug costs. Pharmacy Times. May 11, 2018. pharmacytimes.com/news/president-trump-urges-more-competition-to-lower-drug-costs. Accessed May 23, 2018.
• Sullivan P. Ryan: ‘compromise’ in the works for controversial drug pricing bill. The Hill. May 17, 2018. thehill.com/policy/healthcare/388196-ryan-compromise-being- worked-out-on-controversial-drug-pricing-bill. Accessed May 23, 2018.