No more “freeloaders” in clinical development?

While “America First” is a rallying cry for supporters of President Donald Trump, one thing they don’t want to be first in is prescription drug pricing. Following up on last week’s proposal to mandate the displaying drug pricing in TV ads, the US President took aim at the pharmaceutical industry for charging more in the States as compared to other industrialized nations. He criticized those countries for freeloading on the US’s inflated prices saying, the “American middle class is effectively funding virtually all drug research and development for the entire planet.” To address this, the Department of Health and Human Services released a proposal that would tie Medicare Part B payments for medicines to the levels that other nations pay. HHS Secretary Alex Azar did note this could cause companies to stop selling some drugs in other countries… probably not a big concern for the America First crowd.

Show me the drug money

While any DTC drug commercial will likely include shots of people happily hiking and a list of side effects longer than the symptoms of the disease it’s curing, one thing you won’t see advertised is the price of the prescription. New federal policy could change that for drugs covered under Medicare and Medicaid, forcing companies to disclose list prices in TV advertisements. While most patients don’t typically pay the full price for their prescriptions, Health and Human Services Secretary Alex Azar says, “They deserve to know if the drug company has pushed their prices to abusive levels.” PhRMA says their members would be willing to include a link to a website that has pricing information in advertisements, to which Azar pretty much replied, that’s not what I meant.

Take this cancer test with a shaker full of salt

Genetics company 23andMe—popular for their DTC ancestry tests—has been FDA approved for their mail-order breast cancer tests. Consumers can check whether they possess one of three mutations to their aptly-named BRCA1 and BRCA2 genes, which increase breast cancer risk by 45%-85%. Thing is, there are 1,000 known variations of those genes, and it doesn’t even test the most common. Also, the genes tested mainly affect women of Ashkenazi Jewish descent. Also, if a patient doesn’t test positive for these mutations they may think they’re in the clear breast cancer-wise. Also, some physicians are worried about the mental health effects of learning you may be at risk for cancer without being counseled through it by a professional. But hey, they send the tests to your home so that’s convenient!

Apple and Amazon are all over healthcare

CNBC noticed Amazon quietly launched a partnership in August with OTC manufacturer Perrigo to create their Basic Care line of products. While Amazon may not be the ideal fix for when you need that bottle of cold medicine ASAP, the company could be in a good position to corner the market on products that are bought in bulk like nicotine gum. Apple’s healthcare foray is more tech-focused: they’re developing the next attempt at personal, electronic health records. The idea is to use patients’ smartphones as the unified repository for health records that could otherwise be scattered across healthcare providers. More complete records and data could drive recommendations for care, and could even translate into partnerships with pharma companies to pitch their products directly to consumers fitting a certain profile.

Swab, Spit, or Blood

We’ve all seen the Ancestry.com ads for DNA tests that reveal your ethnic mix. Harmless enough. But what if a similar test indicated you had a low risk for coronary heart disease? Would you start swallowing these 2,000+ calorie bombs at every meal? Not harmless. Consumers are increasingly embracing genetic health risk (GHR) testing to understand their individual risk for developing diseases and the FDA recently released an update to streamline the development and review pathway for GHR tests. These tests can be valuable for drug development (see how Novartis is using genetic testing in an Alzheimer’s trial) and treatment decisions and the CDC has some thoughts on the topic.

It won’t be too hard to let go

The days of feigning disinterest while an attractive woman passes a pigskin between her hands are over: Viagra and Cialis’ four hours of fame have ended. While the drugs have performed well since launch, they’re getting close to reaching that peak point, after which they’ll immediately fall asleep. We’re talking about the end of their patent exclusivity, of course. While Viagra’s doesn’t officially end until 2020, two generic formulations are approved to hit the market by December of this year, which will lead to some profit shrinkage for Pfizer. Eli Lilly’s Cialis will suffer from the same stiff competition penetrating the ED market, so the companies have pulled out of spending the $50 million they usually use on NFL advertising.