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In This Issue
Note: Congress is in recess until September 9. Letters and Statements Gene Therapy: Democratic Senators Urge the FDA to Hold Company Accountable for Falsifying Data On August 9, 2019, a group of Democratic senators, including two presidential candidates, sent a letter to the FDA criticizing AveXis, a Novartis subdivision, for falsifying data in order to obtain approval for its new gene therapy, Zolgensma. The letter urged the FDA to hold the company accountable through all appropriate criminal, civil, and regulatory actions and to restore public confidence in the agency’s approval process. The senators also requested an explanation from the FDA for why the agency decided to withdraw a proposed regulation in October 2018, which would have required sponsors of certain clinical trials to promptly report suspected data falsification to the FDA. According to background information included in the press release on the letter, Zolgensma was described as the most expensive medication in American history, with a price tag of $2.1 million. On May 24, 2019, the FDA approved Zolgensma for children with a severe form of spinal muscular atrophy, an important medical breakthrough for a vulnerable patient population. However, AveXis failed to disclose to the FDA the inaccuracy of its product testing data until June 28, 2019—despite apparently having prior knowledge of the issue in March. AveXis was the beneficiary of numerous federal taxpayer-funded benefits and incentives, including National Institutes of Health (NIH) research and accelerated FDA reviews. “It is unconscionable that a drug company would provide manipulated data to federal regulators in order to rush its product to market, reap federal perks, and charge the highest amount in American history for its medication. Such greed cannot be condoned by the FDA,” the senators wrote. “This scandal smacks of the pharmaceutical industry’s privilege and greed, and Americans are sick of it.” The letter was signed by Sens. Richard Durbin (D-IL), Tammy Baldwin (D-WI), Bernie Sanders (I-VT), Elizabeth Warren (D-MA), and Richard Blumenthal (D-CT). Gene Editing: House Committee Members Urge the FDA to Change Approach A bipartisan group of more than 20 House Energy and Commerce Committee members sent a letter to the FDA on July 26, 2019 urging the agency to develop a more appropriate, workable approach to animal biotech regulations. The group lamented that the current approach threatens farmers and consumers’ access to this technology, while driving research to foreign competitors. As WSGR explained in a recent alert, livestock groups and certain segments of the biotech industry have expressed concerns that the FDA process treats any gene-edited animal as an animal drug, and any livestock operation as a drug manufacturing facility; they describe the process as lengthy and burdensome, which ultimately harms U.S. competitiveness. These groups long have viewed the USDA’s Animal Plant Health and Inspection Service (APHIS) as the more appropriate federal agency to conduct oversight of gene editing in food-producing animals. Drug Supply: House Committee Leaders Seek FDA Briefing on Heparin Supply The bipartisan leadership of the House Energy and Commerce Committee sent a letter to the FDA on July 30, 2019 requesting briefings on the potential threat to the U.S. supply of heparin, the only anticoagulant drug used for open-heart surgeries and kidney dialysis. Raising concerns over the outbreak of African swine fever in China's pig population, which endangers the source from which heparin is derived, the committee leaders requested information on any contingency plans in the event of a serious shortage of heparin. The letter noted, “U.S. dependence on Chinese heparin and on one animal source raises risks of shortages.” The letter was signed by Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Oversight and Investigations Chair Diana DeGette (D-CO), Oversight and Investigations Ranking Member Brett Guthrie (R-KY), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), and Health Subcommittee Ranking Member Michael C. Burgess, M.D. (R-TX). Foreign Drug Manufacturing Facilities: Grassley Urges the FDA to Implement Unannounced Inspections The Senate Finance Committee Chairman Charles Grassley (R-IA) sent a letter to the FDA on August 7, 2019 urging the agency to reinstate unannounced inspections of prescription drug manufacturing facilities in foreign countries. Grassley explained that the reinstatement should occur in light of the administration’s new “Safe Importation Action Plan” as well as the fact that these facilities provide most of the ingredients for production inside the U.S. In the letter, Grassley argued, “Unbeknownst to many consumers...80 percent of Active Pharmaceutical Ingredients are produced abroad, the majority in China and India; however, the FDA only inspected one in five registered human drug manufacturing facilities abroad last year.” “I strongly encourage the administration’s demonstration projects to include unannounced inspections in foreign manufacturing facilities to determine whether they meet the required Active Pharmaceutical Ingredients and drug quality and safety standards to include sufficient record-keeping, testing and protections against counterfeiting,” the letter concluded. Legislation Senate
House
Wilson Sonsini Goodrich & Rosati’s FDA Regulatory, Healthcare, and Consumer Products Compliance practice group is actively following developments on Capitol Hill that impact life science and consumer product issues. For more information on the items above, please contact Brian Ronholm, David Hoffmeister, Jamie Ravitz, or Georgia Ravitz. If there are questions related to antitrust perspectives on these issues, please contact Seth Silber or Thu Hoang in Wilson Sonsini Goodrich & Rosati’s Antitrust practice group.
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