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31 t m c » p u l s e | m ay 2 0 1 9 "When I've spoken with drug companies, the gap is with them understanding what the demand is in order for them to make the right amount and for them to know that they're going to have purchasers of that product," Bernhardt explained. "If there are 20 companies out there and they're all making thioguanine, and they're all making enough for 18,000 children, well that's too much— we don't have that many kids with leukemia every year. A perceived surplus may then drive a reduc- tion in production, which can result in shortages. We have to find a way to match the demand with the supply so that we can come to a better price point, which will drive manufacturing." If hospital associations provided data to help create forecasting models, Bernhardt said, that information could be shared with regulatory bod- ies and manufacturers to create a system based simply on supply and demand. "When you think about countries overseas who say that certain drugs are on their essential medicines lists, they're taking another step and saying, 'How much do we have to budget to pay for those drugs?'" Bernhardt said. "That's some- thing that we haven't really done as a country because we have so many private pay, cash pay, third-party payers. And when you look at some- thing like CMS [Centers for Medicare & Medicaid Services], a good question to ask is how we can leverage our regulatory framework to help drive manufacturing." Legislation likely would be necessary, as well, Berg added. "I don't think pharma companies are evil, but they have certain responsibilities that are economic," she said. "I think we need to make some incentives and maybe some regulation that spreads that burden in some reasonably fair way across the pharmaceutical landscape." The supply-and-demand model has worked well for other areas of medicine. The Centers for Disease Control and Prevention works with a multidisciplinary group called the Advisory Committee on Immunization Practices to develop recommendations related to vaccines. Each year, manufacturers can adjust production of the influ- enza vaccine based on models and predictions for the upcoming flu season. "This group helps estimate how much vaccine will be used so that the companies know how much to produce," Bernhardt said. "There's an expected demand and then there's a supply that's produced in anticipation of that demand." The problem has a solution, Berg said, but it's a matter of whether voters, policymakers and institutions are willing to address the underlying issues that are creating these shortages. "We really need to think in this country about health care and whether we want to be able to say that everybody can get it or not," she said. "If we say, 'You know what, we're just not going to guarantee as a country that every kid with cancer can get adequate treatment'—I don't know anybody who would be very comfortable saying that that's our national choice. But the decisions that we make about insurance and payment and drug pricing—those decisions are also making that decision." Source: FDA "Report on Drug Shortages for Calendar Year 2017" 50 100 150 200 250 300 ■ FDA's Center for Drug Evaluation and Research '17 '16 '15 '14 '13 '12 '11 '10 178 251 117 44 44 26 23 39 NUMBER OF NEW DRUG SHORTAGES PER YEAR, 2010 – 2017