Amid controversial price hikes and surprising regulatory decisions, many aspects of the drug industry were scrutinized this past year.
Here are five drugs that made headlines in 2016.
1. EpiPen
When Canonsburg, Pa.-based Mylan acquired the epinephrine auto-injector in 2007, the lifesaving medication cost $57 for a pack of two. Now, a two pack of EpiPens has a list price of $608, marking a 400 percent price increase. In August, Mylan faced a storm of criticism from politicians, consumers and the media over its pricing practices. A month later, Mylan CEO Heather Bresch was grilled with questions about the high price of EpiPens during a hearing with the House Committee on Oversight and Government Reform. In October, Mylan reached a $465 million settlement with the federal government over accusations the Canonsburg, Pa.-based drugmaker improperly classified EpiPens as a generic drug to overcharge Medicaid.
2. Eteplirsen
The Food and Drug Administration approved Sarepta Therapeutics' drug eteplirsen in September as the first treatment for Duchenne muscular dystrophy. In late May, the FDA deferred its decision on whether to approve eteplirsen after an advisory panel concluded the drug was not effective. The deferral spurred an intense and emotional campaign from patients, parents and physicians calling for the drug's approval, as it was the only potential treatment available for the disease.
The months-long review process also sparked a heated internal debate in the Food and Drug Administration. While FDA staff who reviewed the drug's application opposed approval saying there was no proof of the drug's efficacy, an FDA director overruled the group and the agency approved eteplirsen in the fall under an accelerated approval program. Analysts suggested the move could set a dangerous precedent by dropping the standard level of efficacy required for approval to an unseen low, while some critics questioned whether emotions tied to patient advocacy efforts affected the agency's decision.
3. Naloxone
The price of the opioid overdose naloxone has steadily increased over the past year, complicating health officials' attempts to expand access to the drug amid a national opioid epidemic. While the drug has been on the market since 1971 and five versions of naloxone are now available, the price of the antidote continued to rise in 2016. Hospira charges $142 for a 10-pack of the drug, marking a 129 percent increase from 2012. A two dose-package of the brand name version Evzio costs $4,500, jumping more than 500 percent from 2014 to 2016. The price hikes have caused some emergency response departments to run out and not restore supply of the antidote, while many public health groups must rely on donations to buy the drug.
4. Insulin
Novo Nordisk — the largest insulin maker in the world — made headlines in September when it cut 1,000 jobs, citing slumping profits in the U.S. diabetes treatment market as part of the reason for the workforce reduction. In early November, several politicians called on federal antitrust regulators to investigate multiple drugmakers, including Novo Nordisk, suggesting they intentionally set high prices for insulin and other diabetes medications. The wholesale price of insulin, used to regulate blood sugar levels in patients with diabetes, skyrocketed from $45 in 2001 to nearly $1,447 in 2015 for a 30-day supply. After years of insulin price hikes, Indianapolis-based Eli Lilly & Co. unveiled a new discount program for its insulin products in December. The company produces several insulin products, including Humalog, which has jumped in cost from $21 a vial in 1996 to $255 in 2016.
5. Harvoni and Sovaldi
Gilead Sciences' hepatitis C treatments Harvoni and Sovaldi are well-known among the healthcare world for their notably high prices, which continued to draw media attention in 2016. Retail prices for the pills are $1,000 and $1,200 for the pills, respectively, with full treatment costing between $83,000 and $95,000. Medicare data released this year ranked Harvoni as the agency's costliest prescription drug in 2015. Another report came out in July, showing Medicare spending for all hepatitis C treatments doubled in just five months, increasing from $421 million in November 2014 to $864 million in March 2015. By the middle of 2015, spending on the medications plateaued at $793 million.
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