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Regulatory Focus™ > News Articles > 2020 > 3 > House Committee Wants FDA Briefing on Marketing Status Reporting Requirements

House Committee Wants FDA Briefing on Marketing Status Reporting Requirements

Posted 09 March 2020 | By Michael Mezher 

House Committee Wants FDA Briefing on Marketing Status Reporting Requirements

A bipartisan group of representatives on the House Energy and Commerce Committee last week called on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to brief them on marketing status reporting requirements for new and generic drugs.
 
Background
 
Under the FDA Reauthorization Act of 2017 (FDARA), drugmakers are required to provide notice before withdrawing a drug from sale or when a drug will not be made available for sale within 180 days of its approval.
 
FDARA also required drugmakers to review the status of their approved drugs in the active section of FDA’s Orange Book and submit a one-time report certifying that their listed drugs are available for sale or whether any of the drugs have been withdrawn from sale or were never made available for sale.
 
In 2019, FDA issued draft guidance explaining how sponsors can comply with the marketing status reporting requirements laid out in FDARA.
 
Letter
 
In the letter, the representatives ask Hahn to brief them on temporary market withdrawals reported under Section 506I of FDARA and on how FDA is tracking the marketing status information it receives.
 
The representatives also ask what actions FDA is taking to address any “gaps or overlaps” in marketing status reporting requirements.
 
"Promoting a competitive marketplace depends in part on FDA’s timely approval of generic drugs and biosimilars, and in part on transparency about the marketing status of approved products," write Committee Chairman Frank Pallone (D-NJ), Ranking Member Greg Walden (R-OR), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), Health Subcommittee Ranking Member Michael Burgess (R-TX), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-KY).
 
The representatives’ request comes after 44 states filed a complaint against 20 generic drugmakers last May alleging that the companies engaged in price fixing and market manipulation, in some cases by “temporarily delisting” products in order to re-enter the market  at a higher price at a later date.
 
“As one example, in July 2013, Defendant Sandoz was looking to implement a ‘Taro Strategy’ that involved temporarily delisting ten products that they overlapped on with Defendant Taro. This strategy would allow Taro to raise price on these products while Sandoz was out of the market, and then Sandoz could re-enter later at a higher price,” the states allege.
 
While Novartis and Sun Pharma, the parent companies of Sandoz and Taro, denied the claims made in the complaint, Sandoz last week admitted to criminal conspiracy charges involving price fixing and agreed to pay a $195 million fine. In February, former Taro executive Ara Aprahamian was indicted for conspiring to fix generic drug prices. Both actions are part of an ongoing federal antitrust investigation into generic drug price fixing.
 
Specifically, the representatives requested Hahn brief them on temporary market withdrawals reported under Section 506I of FDARA and on how the agency is tracking marketing status information.
 
House Energy & Commerce Committee

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