As a prelude to Tuesday's Senate Judiciary subcommittee hearing on competition in the U.S. economy, several Democratic senators wrote to the FTC to express concerns about the impact of consolidation in the U.S. biopharma market. The senators – led by Sen. Amy Klobuchar (D-Minn.), ranking member of the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights – urged the FTC to closely scrutinize biopharma mergers that raise competition issues. The letter specifically called out Abbvie Inc.'s $63 billion bid for Allergan plc and Bristol-Myers Squibb Co.'s proposed $74 billion acquisition of Celgene Corp., saying that the deals raise significant antitrust issues. The senators also noted that M&As are expected to increase in the sector. What's concerning about that, according to the letter, is the potential impact on innovation, which relies on research and competition to discover new therapies. "Reports indicate that Abbvie is planning $1 billion in research and development budget cuts to pay off debt after the merger closes, which does not bode well for innovation at the combined company going forward," the senators said. "If these mergers reduce innovation, competition and patients will suffer." Another concern mentioned in the letter is that mergers will give biopharma companies increased negotiating leverage to force buyers to provide them with more favorable pricing terms across multiple product categories. That leverage could help lay "rebate traps" in which the large companies secure favorable formulary positions by offering volume-based rebates that smaller competitors can't match. Those traps could prevent alternative drugs, including biosimilars and generics, from competing. The letter also asked the FTC to ensure that products divested as part of anticompetitive settlements in an M&A are able to compete effectively in the market. Too often, the divested product is in the development stage, while the company keeps more viable products that are already on the market, the senators said. (See BioWorld, June 26, 2019, and Aug. 29, 2019.)

A bill awaiting California Gov. Gavin Newsom's signature could make drug patent settlements more challenging, if it withstands potential appeals. AB 824 presumes drug settlements are anticompetitive if a generic or biosimilar sponsor receives anything of value in exchange for limiting or delaying generic entry. While open to some interpretation, "anything of value" would include an exclusive license or promise that an authorized generic won't be launched. The bill sets civil penalties at three times the value paid under the settlement or $20 million, whichever is greater. By shifting the burden to drug companies to prove an agreement isn't anticompetitive, the bill goes beyond the 2013 Supreme Court ruling in FTC v. Actavis Inc. In that 5-3 decision, the court refused to presume all reverse-payment, or pay-for-delay, settlements were anticompetitive. Instead, it recognized that there may be justifications for some payments, so it is up to the government to prove that they're anticompetitive. In addition to the change in presumption, the California bill would require greater transparency on the terms in patent settlements. (See BioWorld, June 18, 2013.)

The FDA released its final guidance on citizen petitions Wednesday, addressing the practice of brand companies submitting certain types of citizen petitions to delay generic or biosimilar competition. "While the FDA has rarely delayed specific drug approvals because of citizen petitions, there's no doubt these shenanigans can burden the drug review process," Acting FDA Commissioner Ned Sharpless said. The guidance aligns the agency's 150-day response time to such petitions with the timeline for reviewing abbreviated applications. The approach should lessen the impact FDA review of the petitions may have on pending approvals and help the agency efficiently allocate resources when handling petitions that may present an obstacle to the availability of generics or biosimilars. In addition, the guidance outlines the FDA's intent to refer companies that try to game the petition process to the FTC. "To further dissuade companies from improperly using these petitions, the FDA will highlight in our annual report to Congress our determinations of petitions that are judged by the agency to have been submitted with the primary purpose of delaying an approval," Sharpless said.

Going a step further than other drug regulators, Health Canada has asked companies to stop distributing all ranitidine drugs in Canada while it assesses the extent of N-nitrosodimethylamine (NDMA) impurities detected in some of the antacid drugs. In announcing the step it had taken, Health Canada said Tuesday that it was an "interim, precautionary measure." Pharmacies and stores in Canada may continue to sell existing stock of prescription and over-the-counter ranitidine products. Meanwhile, Sanofi Canada is recalling all its oral prescription Zantac (ranitidine) products in the country after testing identified levels of NDMA above acceptable levels, according to Health Canada. Australia's Therapeutic Goods Administration (TGA) said Tuesday that it's testing ranitidine drugs in Australia to determine if they contain the potential carcinogen. While the TGA hasn't stopped distribution of the drugs, it is warning that it's anticipating a recall and a possible shortage of the heartburn drugs. The EMA and FDA announced last week that they were investigating how low levels of NDMA got into ranitidine drugs. Neither agency had reported recalls yet, and they were still evaluating whether the NDMA levels in the drugs posed a risk to patients.

The cost of getting to FDA approval based on trials conducted by the NIH's National Cancer Trial Network (NCTN) can be much less than the cost of an FDA approval from trials run by drug companies, a new study suggested. Conducted by researchers from the NCTN's SWOG Cancer Research Network, the study looked at 182 NCTN phase III trials from 1980 to 2017 that involved SWOG participation. Across all the completed trials, the average cost was $7.5 million per trial. When broken down further, the average cost was $16.6 million per trial that influenced clinical practice and $123.6 million for a new drug approval. In contrast, a review of 10 studies of the cost of new drug approvals based on industry-run trials found that the mean inflation-adjusted cost for a single new drug approval was $1.73 billion. The study authors acknowledged that this kind of cost comparison is imperfect because regulatory costs can make industry-sponsored trials more expensive, but it still shows the value of NCTN trials, they said. The study, published in JAMA Network Open, also found that 82, or 45%, of the 182 NCTN trials led to clinical care guidelines or new drug approvals. Of those 82 trials, 35, or 43%, had negative findings, with nearly half of the 35 trials reaffirming the standard of care compared with experimental therapies being tested in the trials. Negative trials also can reveal harmful side effects caused by experimental therapies, the researchers said.

Results from a collaboration between Iqvia and Friends of Cancer Research substantiate the validity of using real-world data to support regulatory and payer decision-making, according to researchers involved in the study. Part of a cross-industry effort to advance the use of real-world evidence, the study involved six research centers in the U.S. and followed a common protocol to assess real-world endpoints among cancer patients, including overall survival, time to next treatment, time to discontinuation of treatment, time to progression and progression-free survival. The researchers used nonidentified patient data from sources such as administrative claims and electronic health records to assess the real-world endpoints. They found that the data were generally consistent with each other and with outcomes observed in randomized clinical trials, confirming that clinical benefits seen in trials were consistent with the benefits in real-world settings. "While randomized clinical trials are the gold standard to evaluate whether a medical treatment can work, they don't determine if treatment works for diverse patients outside the clinical setting and within real-world situations," said Nancy Dreyer, Iqvia chief scientific officer and an author of the study report. She added that the study "demonstrates the value of real-world evidence to measure and quantify the comparative benefits and risks of various medical products." Results from the study were recently published in JCO Clinical Cancer Informatics.

The Bill & Melinda Gates Foundation awarded a $360,000 grant over two years to support research at the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) on the safer use of medicine during pregnancy. MHRA specialists will use prediction models to develop recommended medicine dosages during different trimesters of pregnancy to ensure effective use.

The U.S. Department of Justice (DoJ) charged Yu Zhou and Li Chen, of San Diego, with wire fraud and the theft of exosome-related trade secrets from Nationwide Children's Hospital's Research Institute in Ohio. (Exosomes play a key role in the research, identification and treatment of several medical conditions, including necrotizing enterocolitis, liver fibrosis and liver cancer.) The couple worked in separate labs at the institute for 10 years. During that time, and without the hospital's knowledge, they allegedly founded a company in China, which marketed products and services related to exosome isolation. The couple also, in 2017, helped start an American biotech company that marketed multiple products and services related to exosome isolation, including a kit developed from a trade secret created at the research institute, according to DoJ. Zhou and Chen allegedly used the institute's resources and equipment to conduct the exosome research necessary for their unauthorized, outside work. DoJ said the couple allegedly received more than $876,000 and stock in November 2017 as part of an asset purchase agreement with the U.S. company, and Zhou had a stock purchase agreement with the company under which he would receive $450,000.

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