A World Trade Organization (WTO) dispute panel handed the U.S. a victory Thursday, saying India is providing more than $7 billion a year in prohibited export subsidies to Indian producers of pharmaceuticals, chemicals, information technology products and other goods, according to the U.S. Trade Representative. The WTO panel gave India six months to withdraw the prohibited subsidies it pays through its Merchandise Exports from India Scheme (MEIS), Export Oriented Units Scheme, Special Economic Zones (SEZ), Promotion Capital Goods Scheme and a duty-free imports for exporters program. The WTO expressly forbids export subsidies that give an unfair competitive advantage to recipients, but it exempts specified developing countries from that rule until they reach a defined economic benchmark. India's exemption expired in 2015 when it surpassed the benchmark, but the country refused to withdraw its export subsidies, saying it was entitled to extra time. India expanded the programs, the USTR said, noting that MEIS now includes more than 8,000 eligible products, nearly double the number of products covered since its introduction in 2015. SEZ exports increased more than 6,000% from 2000 to 2017, accounting for more than $82 billion in exports in 2016, or 30% of India's export volume.
The FDA released a draft guidance to help sponsors develop drugs to treat chronic hepatitis D virus (HDV) infections, which occur in conjunction with hepatitis B infections and can impair liver function and cause long-term liver problems. Because chronic HDV infection is considered serious and life-threatening and there are no FDA-approved treatments, investigational anti-HDV drugs may be eligible for the agency's expedited development and review programs. The guidance discusses the overall development program for the drugs and clinical trial designs. Comments on the draft should be submitted to docket FDA-2019-D-4042 by Dec. 31.
The FDA is revising its 2017 draft guidance on assessing user fees under GDUFA II. The draft addresses changes in user fee assessments from GDUFA I, user fees incurred by the generic drug industry under GDUFA II, payment procedures, and reconsideration and appeals. The revision includes clarifying language based on public comment on the original draft guidance, according to a notice slated for publication in Friday's Federal Register. Comments on the revised draft should be submitted to docket FDA-2012-D-0880 by Dec. 31.
The U.S. Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information to inform a review on interventions for dyspnea in patients with advanced cancer. The review is being conducted by AHRQ's Evidence-based Practice Centers (EPC) Program. AHRQ is asking for lists of completed and ongoing studies for the indication. All materials submitted must be publicly available or able to be made public, according to a Federal Register notice scheduled for publication Friday. Once it's completed, a draft of the review will be posted on the EPC website and will be available for comment. Information for the review should be mailed or emailed to EPC by Dec. 1.
Contextmedia Health LLC, a Chicago-based digital provider of medical information and advertising in doctors' offices, agreed to pay $70 million to biopharma companies and others that were victims of a fraud scheme as part of a non-prosecution agreement with the U.S. Department of Justice (DoJ). Operating as Outcome Health, the privately held company admitted that from 2012 to 2017, former executives and employees sold advertising inventory that the company didn't have. Outcome employees falsified affidavits and proofs of performance to make it appear the company was delivering advertising content in accordance with clients' contracts. They also inflated metrics regarding how frequently patients engaged with Outcome's devices. The company admitted that one executive altered studies presented to clients to make it appear that the campaigns were more effective than they were. The company said its under-delivery on advertising campaigns resulted in a material overstatement of its revenue for 2015 and 2016. Employees and executives fabricated data to conceal the fraud from auditors and then used the revenue figures to raise about $972.5 million in debt and equity financing in 2016 and 2017.