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.

Important imports?

The Department of Health and Human Services has directed the FDA to consider the importation of foreign drugs to address price spikes. The proposed policy would only apply to drugs unaffected by patent or exclusivity, in an effort to avoid intellectual property issues. However, pharma companies may still have something to say through their lawyers if such a policy were to be implemented, especially as an act of a federal agency instead of legislation. If it were implemented though, it would avoid patient access issues in situations like when an HIV medication jumped in price from $13.50 to $750, which had the incredibly unfortunate side effect of catapulting Martin Shkreli’s infinitely punchable face into the limelight. That drug still costs $750 by the way. Or just 5-10 cents in India.

Pfizer postpones price hikes

Pfizer announced price increases on about 40 drugs at the beginning of July. But after discussions with President Donald Trump and Health & Human Services Secretary Alex Azar, they’ve decided to cut-it-out. Trump had lambasted drug companies earlier in the week for price increases, noting that other markets like Europe get lower prices. After their meeting, Pfizer decided to roll-back the increases to pre-July figures, “to give the president an opportunity to work on his blueprint to strengthen the healthcare system and provide more access for patients.” And they’re leaving the price drops announced at the beginning of the month intact. The hikes aren’t completely gone though, Pfizer’s just holding off until 2019 or until that aforementioned blueprint takes effect. For a (pink) blueprint you don’t have to wait for, click here.

$1.23 per person in the US

Earlier this week FDA Commissioner Scott Gottlieb outlined the FDA’s request for additional funding. In summary, “additional resources will help advance initiatives to support novel medical technology and public health priorities such as generic drug development, pharmacy outsourcing, and novel domestic manufacturing capabilities.” Cool. $400 million worth of cool, or just $1.23 per individual in the US. Count me in. The current US 2019 budget would boost funding for the FDA to ~$5.8 billion from the current level of $5.1 billion, so the $400M request is really just asking for a 7.8% increase. If you are really interested/bored, you can view the “brief” version of the HHS budget here, all $95.4B of it. Want to see what you can fill your Amazon cart with for $1.23, look no further.

Eli Lilly exec pegged for HHS secretary

Replacing President Trump’s initial pick to lead the US Health and Human Services department is recent Eli Lilly alum Alex Azar. Trump expects that experience will give him a good grip on how to better deliver healthcare and lower drug prices. However, some critics are unhappy about the appointment of a “Big Pharma” figure to run the US’ most well-funded department. Eli Lilly and other large drug makers like Johnson & Johnson and Merck have actually made some advances in drug pricing transparency recently. Earlier in 2017 they released high-level reports explaining price hikes, and shifted the blame for high healthcare costs to other players like PBMs. However, these too were criticized for not being granular enough. Well, you can’t please everyone.

This article is not FDA approved (but let’s be honest, they’d like it)

Are you thinking about selling a product through your Instagram that claims to prevent or even cure cancer? Don’t. The FDA is cracking down on 14 companies illegally selling 65 fraudulent products through websites and social media making those same claims. A press release issued by the FDA states these products are being marketed for use in humans and pets and come in the form of “pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices).” Warning letters have been sent to these companies, and not complying with these letters could result in criminal prosecution. Next time you see a product like this, or this, and think “well that sounds ridiculous,” trust yourself.