�Թϲ�����

During my 19 years as a research scientist at the Upjohn Company, the regulatory burden imposed by the open-ended Drug Amendments Act of 1962 was mushrooming. My coworkers and I joked that because of this dramatic change to the mission of the FDA, made largely as a response to the European thalidomide crisis, we spent so much time meeting the FDA’s development demands that we had little time to discover new drugs. (Mary J. Ruwart, 10/1)

When you’re desperately ill, your chances of relief and recovery improve as your access to treatment improves. That’s why it’s such good news that the Food and Drug Administration (FDA) is working to speed up the process of getting new medications to patients. The FDA has two critical missions. One is to ensure that medications approved for sale to patients are safe and effective. The other is to get effective treatments to patients as quickly as possible. (Peter Pitts, 9/28)

The market for migraine medicines is getting better and better for patients. And for the companies that are crowding into it, it has the potential to be a drug-price proving ground. The Food and Drug Administration approved Eli Lilly & Co.’s Emgality on Thursday, 13 days after it OK’ed Teva Pharmaceutical Industries Ltd.’s similar Ajovy, and less than five months after the first approval in the class, for Novartis AG and Amgen Inc.’s Aimovig. (Max Nisen, 9/28)

Over the first two years of his administration, President Trump has prioritized policies that promote American competitiveness and U.S. interests in trade deals as well as focus on lowering the cost of healthcare and the price of medicines. Trump can make huge progress toward achieving these goals by ensuring the U.S. negotiates trade deals that get tough on foreign price-controlled medicines and allow innovation to flourish. (Grover Norquist and Alex Hendrie, 9/26)

For quite some time, consumer groups, patient advocates, and even several medical professional societies have called for direct-to-consumer (DTC) advertisements to include information on drug pricing. In June 2017 the American Medical Association put out a statement explicitly arguing in favor of inclusion of drug prices in DTC advertisements. (Joshua Cohen, 9/24)

When Pfizer Inc. CEO Ian Read steps aside in January, the legacy he’ll leave behind won’t be the one he intended. Read, whose move was announced early Monday, attempted the two biggest pharma deals in history when he went after AstraZeneca PLC and Allergan PLC, only to be stymied by target resistance and regulators. He’ll just have to settle for having navigated a difficult series of patent expirations — and a 162 percent increase in the stock price. (Max Nisen, 10/1)

Five-year-old Aurora Pugh of Farmington, Minnesota, loves swimming and dancing. She also suffers from severe epilepsy. After spending months taking dance lessons, “Aurora slept through her first dance recital after an overnight seizure and we could not get her to wake up,” her mother, Lindsay Pugh, said. “As parents, that was a difficult moment.” Aurora’s epilepsy diagnosis, Lindsay said, has “made us appreciate every moment more.” But the high costs of her medications have strained the family’s finances. Lindsay must always have a rescue medication—known as Diastat—on hand in case Aurora has a seizure that lasts longer than about three minutes, and that medication can cost her up to $560 for just two doses. Aurora has had as many as six seizures in a single week, so Lindsay has sometimes had to purchase Diastat five times in just a month. (Joel Dodge and Sean McElwee, 10/1)