Photo credit: Bill Brooks/Creative Commons

1. Drug pricing goes public: In the past year, what was once an issue debated among few stakeholders in the medical community became a talking point in presidential campaigns. (Bill Clinton’s words of advice to pharma: “Explain, explain, explain; disclose, disclose, disclose.”) The issue of how and why drugs are priced the way they are hit a tipping point, as insurers, pharmacy benefit managers, physicians and even presumptive presidential candidates questioned pharmaceutical pricing practices and called for changes to the current system.

2. Amarin makes its case against the FDA: Amarin’s decision to sue the FDA over allegations that the agency restricted its free speech gave the pharmaceutical industry one more leg up in its battle to lift restrictions against off-label marketing. While the broader ramifications for other drugmakers are unclear, Amarin’s legal win will likely boost its sales and open the door for similar lawsuits.

3. The FDA takes on the Kardashian marketing machine: The agency in August issued a warning letter to Duchesnay over Kim Kardashian’s social-media promotion of the drugmaker’s morning-sickness drug, which shows the FDA’s Bad Ad program works on social media, too. The celebrity later posted corrective posts on Instagram and Twitter with updated—and lengthy—information about the drug’s risks rather than just its benefits. At the same time brand awareness for Diclegis went up, by 500%, which highlights the tension between the FDA’s regulations for drugmakers and how the public uses social media.

4. PBMs exert their influence: Following the Sovaldi formulary debacle of years past, PBMs in 2015 flexed their formulary powers, boosting the number of drugs they excluded on their formularies and signing aggressive deals with the makers of the new PCSK9 inhibitors. The power PBMs are able to yield will likely mean pharmaceutical companies will now need to arrive at the bargaining table with more to offer than just a new product.

5. Pharma wins a Grand Prix—kind of: AstraZeneca’s talking fish, Sal and Marty, headlined an unbranded disease awareness campaign that sought to teach men about the dangers of high triglyceride levels. The fish are funny, irreverent and, sadly, not well respected among all of the pharma advertising elite. In 2014 everyone complained that pharma couldn’t win a Grand Prix in Cannes. This year many asked: “Are these fish winners?” (Listen here for more on the Lions Health debate about creativity in pharma.)

6. Pharmaceutical re-pricing practices go mainstream, thanks to pharma’s favorite bad guy: A year ago no one had heard of Turing Pharmaceuticals, Martin Shkreli and Daraprim. Many people, industry insiders included, were familiar with price increases but not the kind the ex-hedge fund operator is now infamous for. (Buy an old drug, hike its price by 5,000%.) Then The New York Times wrote about it, and Shkreli became the perfect scapegoat for drugmakers seeking to evade questions about their own pricing practices.

7. Valeant makes its own contribution to the re-pricing debate: The investor darling also had to address tough questions about the types of agreements it had with specialty pharmacies. But the answers frustrated CEO J. Michael Pearson gave did little to quell investors’ fears. Share prices tanked to a low of $70 from a high in July of $257, and the company’s model is undergoing changes.

8. Doctors call for a ban on DTC advertising: The American Medical Association is not the first organization to call for a ban on pharmaceutical advertising to consumers this year but it’s one of the most powerful. The call for a ban may be symbolic in nature but it still raises questions about how the medical community and the public feel about those late-night erectile-dysfunction drug ads.

9. Pfizer announces plans to buy Allergan for its Dublin address, says it’s good for the portfolio: Pfizer’s $160 billion acquisition of Allergan will create the world’s largest drugmaker and one of the world’s largest advertisers. It also gives the New York-based drugmaker a chance to move its tax domicile to Ireland and may be the last of the infamous tax-inversion deals that the Treasury Department allows as a result.

10. Afrezza’s DTC campaign fails to boost sales: Investors had eagerly awaited the blockbuster that was supposed to be Afrezza, the inhaled insulin developed by MannKind and marketed by Sanofi. Sales were low—the companies said it had to with a lack of awareness. The campaign launched. Sales are still lower than expected.