House Committee Discusses Bipartisan Bills on Orphan Exclusivity, Generic Drug Labels and More

Regulatory NewsRegulatory News | 29 January 2020 |  By 

The House Energy & Commerce Committee on Wednesday considered four bills, supported by members on both sides of the aisle, that focus on companies gaming the orphan drug exclusivity process, allowing generic drug companies to update outdated labels with FDA’s help, ensuring counterfeit devices can be destroyed at the border and encouraging continuous drug manufacturing.

In the case of orphan exclusivity, the bill would seek to stop companies like Indivior, which earned orphan exclusivity for its opioid use disorder treatment Sublocade (buprenorphine) after the company initially said it would not be profitable. But the company said in its FY 2018 report that it’s targeting $1 billion-plus of peak annual net revenue from Sublocade and the exclusivity means no competitors will be marketed until 2024.

FDA in November announced its intention to revoke the orphan designation for Sublocade, but Kao-Ping Chua, assistant professor in the department of pediatrics at the University of Michigan Medical School, explained to the committee on Wednesday how this bill, in the event that Sublocade’s orphan status is appealed and not revoked by FDA, would block the exclusivity for Sublocade so that new competitors could come to market before 2024.

But the bill would have a limited impact overall, as only two other drugs since 1983 have earned their orphan exclusivity through this provision of cost recovery. Still, Chua explained how the bill would keep sponsors honest and require them to demonstrate that there is no reasonable expectation of cost recovery during each of the seven years of exclusivity. So if such a drug later became profitable, the orphan exclusivity could be revoked.

Rep. Kurt Schrader (D-OR) called to do away with the cost recovery pathway for orphan exclusivity altogether.

Meanwhile, the proposed bill on updating generic drug labels would help FDA address an issue that has long been a pain point. FDA in December 2018 pulled a proposed rule to allow such updates after the agency said generic drug application holders said the process would be costly and that they do not generally have all the data necessary to evaluate postmarket safety information and to support safety-related labeling changes.

But building off of work to update generic chemotherapy labels, the bill would allow FDA to order companies to make changes to outdated labels, and if the companies do not comply, the drugs would be considered misbranded.

The bill on medical device counterfeits would ensure that FDA has the authority to destroy counterfeit devices at the border so that the inspectors do not have to send the fake devices back to their point of origin, as they do currently. FDA has such destruction authority on the pharmaceutical side.

Richard Kaeser, VP of global brand protection at Johnson & Johnson, explained to the committee how his company discovered counterfeit versions of its Surgicel product to control bleeding during and after surgeries. He said the counterfeit products were removed from the market and no patients were harmed, but counterfeiters are getting better at what they’re doing.

And the bill on continuous drug manufacturing would allow FDA to designate institutions of higher education as a National Center of Excellence in Continuous Pharmaceutical Manufacturing. FDA’s CDER Director Janet Woodcock has been pushing for the increased use of continuous manufacturing since at least 2013.

Fernando Muzzio, distinguished professor of chemical and biochemical engineering at Rutgers, explained the ways the continuous manufacturing is better and faster than batch manufacturing.

In addition to the discussions of the bills, Rep. Greg Walden (R-OR) also asked for a future hearing on an extension of the life of the rare pediatric priority review voucher program, which technically runs out in September 2022, but after 30 September 2020, FDA may only award a voucher if the drug already has a rare pediatric disease designation.



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