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.
Hear InsightCity’s take on Right to Try with this short podcast.
Topics covered include: Right to Try explained, Compassionate Use programs, ambiguity in the legislation, and the role of insurers
The FDA’s Compassionate Use program helps patients that seek access to medications still in the development pipeline. But legislation signed into law this week allows patients to completely bypass the regulatory agency should they so choose. The “Right to Try” bill gives patients access to investigational drugs with the permission of just their physician and the drug manufacturer. It also shields those drug companies from the legal risks involved. Critics, including the American Cancer Society, say the bill gives false hope to patients, and champion the current process of compassionate use and clinical trials. After all, the FDA approves 99% of compassionate use applications, and can even do approvals over the phone. When asked for comment, some formerly prominent musicians said “You gotta fight for your right… to paaaaaaaaarty.”
Ever tried doing your kid’s homework for a week like this dad? It might be worth a try to get a sense of the stresses affecting students these days, and it could make you more sympathetic towards getting some mental health legislation on the books. If you don’t want to, well those dang kids might just get it done themselves. Three high school students recently successfully lobbied the Virginia General Assembly to require mental health instruction for 9th and 10th graders. It’s not about kids just being bratty about too much schoolwork; the CDC estimates 1 in 5 US kids experience mental disorders and $247B is spent on these disorders each year. At least they’ll have a break soon—it’s about that time of year when School’s Out for summer.
This week, two studies in Addiction took aim at some arguments medical marijuana supporters and detractors use when fighting for and against that “dank chronic” (dope list of marijuana slang here.) Medical marijuana supporters argue that opioid abusers would substitute marijuana for pain relief, leading to fewer opioid overdoses. While studies do identify a correlation between a decline in overdose deaths and the passage of medical marijuana legislation, the first study determined that the evidence doesn’t support the laws causing the drop. On the flip side, detractors warn that one of the evils of passing this legislation is more adolescents picking up a pot habit. While that could be bad, the second study couldn’t identify that trend actually occurring in legal weed states.
Apologies if this reads more like an editorial, but really? Two lawmakers in New York have proposed legislation that stipulates laundry detergent manufacturers must manufacture their products with uniform, dull colors in order to not encourage consumption by people. Of course, teenagers consuming laundry detergent is awful but anyone hypothesizing that they’re doing it because the pods look tasty has never met a teenager. I guess law makers gonna try to make laws. According to this article, there’s hope because similar efforts have failed in the past. Also, here’s a list of ridiculous warning labels. Because why not?
A bill proposed in the U.S. House of Representatives, the Protecting Access to Care Act of 2017, would cap noneconomic damages in medical malpractice cases to $250,000. Many healthcare organizations are giving this bill a huge thumbs-up since it’ll allow them to focus less on so-called defensive medicine, bringing down healthcare costs. It also proposes protecting health care providers from being affected by product liability lawsuits against products approved by the FDA. However, opponents argue that it will deny plaintiffs the ability to get full repayment for wrongdoings. It hasn’t been put up for a full House vote yet, but this is definitely an interesting bill to watch. No word yet on if it will protect HCPs from relentlessly insulting anesthetized patients.
Well, President Trump… hey, where are you going? Don’t go yet! The President released his 2018 budget proposal. (We have saved you others’ analyses. This is the source document). Along with many other departments, the NIH may find itself wondering where 20% of its money went (go to p. 22 of the document). Also, prices are going up at the FDA. Plan on submitting a drug for approval? That might cost you double next year. InsightCity recommends you spend a few minutes in this document. It’s surprisingly readable. Also, the President and Congress have until October to come to an agreement so there’s little chance the proposal survives intact. There’s probably a better chance that the government shuts down or that pigs fly.