This will surely be interesting. I doubt that any prescription drug advertised on television is less than 35 dollars a month.

Pharmaceutical companies will have to include information in their television ads about the cost of products if they cost $35 or more for a course of treatment or for a month's supply if a medicine is taken long term, the Trump administration announced today.

The Department of Health and Human Services (HHS) on Wednesday said it finalized a rule that establishes this requirement for prescription drugs covered by Medicare or Medicaid. That classification covers virtually the entire pharmaceutical market in the United States.

For the ads, the list price will be pegged to the wholesale acquisition cost, HHS said. The rule will appear soon in the Federal Register and will take effect 60 days after publication there.

Drugmakers spent more than $5.5 billion on prescription drug advertising in 2017, including nearly $4.2 billion on television advertising, HHS said.

The trade group for drugmakers, the Pharmaceutical Research and Manufacturers of America (PhRMA), on Wednesday criticized the rule. In a statement, PhRMA CEO Stephen J. Ubl said the posting of prices could confuse patients and discourage them from seeking needed medical care.

On a call with reporters, HHS Secretary Alex Azar had a clear rebuttal regarding the PhRMA's concerns. A former top executive at Eli Lilly, Azar advised his former industry colleagues to "level with people" about the cost of medicines.

"Put it in the TV ads. Patients have a right to know," Azar said. "And if you're ashamed of your drug prices, change your drug prices. It's that simple."

Enforcement
With this rule on direct-to-consumer (DTC) ads, HHS is counting on pharmaceutical companies to police their rivals.

The US Food and Drug Administration (FDA) already keeps an eye on drug promotion, looking for instances in which companies underplay the risks or misrepresent the potential benefits of their products. Rather than expanding the FDA's role, HHS has designed a system in which the federal government will publicize violations of the rule and then leave it to private industry to pursue litigation.

At least once a year, the Centers for Medicare & Medicaid Services (CMS) will post online a report on violations of the price-disclosure rule. "We continue to believe that competitors are best positioned to identify and act upon advertisements that violate this regulation," HHS staff wrote in the final rule.

Azar spelled out how the $35 benchmark in the price-disclosure rule would trigger legal action for violations.

"If you do not have compliant information in your television ad, you are implicitly suggesting your drug costs less than $35," Azar told reporters on the call. "And a competitor would sue you."

In writing the rule on price disclosure in DTC ads, HHS cited the Lanham Act, a federal law meant to protect consumers from false advertising. There is already a pool of attorneys who focus on this field of law, said Azar, who himself is a lawyer and has spent much of his career in health policy circles.

"There are very large legal practices built on pharma companies suing each other for violations of the deceptive trade practices provision of the Lanham Act," Azar said. "So this will be a quite effective mechanism of enforcement."

LINK: https://www.medscape.com/viewa...&impID=1964134&faf=1

I hope that one result might be a significant reduction in the number of these ridiculous "ask your doctor" ads for drugs to treat a rash with 8000 side effects. Adding "It only costs $6000/month" might put a bit of a chill on the marketing plan.

Cool. Just another thing to get squeezed into the brief fine print that nobody can read, or into the 150 mph fast-talk disclaimer at the tail end.

quote:

Cool. Just another thing to get squeezed into the brief fine print that nobody can read, or into the 150 mph fast-talk disclaimer at the tail end.

^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
HHS is not stupid. Hopefully that issue will be addressed. The United States is only one of two countries that allow direct to consumer ads.

quote:

Originally posted by ZSMICHAEL:
HHS is not stupid.

Well... it is the federal government... so...

You have a point.

Apparently some of these life extending cancer drugs cost $5000 to $12000 a month or more and a full course can run $300,000. The fine print indicates they may give you six more months and that is not assured. I hope none of us ever need them. When my late Father was in a nursing home, one of the nurses said the family always wants one more procedure for $75000 as long as the government pays for it.

A month back, I was hanging out with some guys and one of them was a physician. The topic of drug advertising came up, and two of us had lived outside the country so we chatted about how drug advertising is way different outside the US. Then, the doc dropped a bombshell which is one of the frequently advertised Hep-C meds is $75k-$100k for a course of treatment.

They seem like a prime reason for this HHS rule.

Problem I see is, pharmaceutical is private.

Where are the same requirements for automobiles, beer, airline tickets, and other items which are locally produced, and sold from, to a the national market?

quote:

Originally posted by LS1 GTO:
Problem I see is, pharmaceutical is private.

Where are the same requirements for automobiles

Since 1958, Federal law has required all new automobiles to be prominently labeled with their MSRP (among other things). That's why all car dealers have window stickers.

Spending $$’s to buy another 6 months (maybe) is insane to me. We all gotta pack our shit anyway, i’ll leave whatever I have to someone.

As I understand it, there are only two or three countries that allow direct-to-consumer pharmaceutical ads. Two of those countries are the US and New Zealand. I actually find the direct-to-consumer advertising useful; it gives you some idea of what new therapies are approved without having to keep up to date on trade journals. Take migraine, for example. Some years ago, research showed that in some cases taking naproxen with the migraine meds could lead to faster symptom relief in some cases. I didn't hear about that until I heard an ad for a new formulation that was Imitrex and Naproxen. How would a hypothetical patient know that he should even ask about such things in the absence of advertising? (Of course, most docs would say "just take 2 naproxen when you take the first dose of your triptan" so the prescription would still be for a generic migraine medication alone, instead of the new non-generic combination pill.)

quote:

Originally posted by MNSIG:
I hope that one result might be a significant reduction in the number of these ridiculous "ask your doctor" ads for drugs

Here's hoping.

The only folks who might mourn the end of that nonsense, are ad agencies.

Yep. They'll put the price in there somewhere.

I wonder if copay cards/cost reduction programs/samples are part of their advertising/promotion budget? I don't necessarily think it is a bad thing for the public to be informed of pharmaceutical choices available to them. In the end the only thing that matters to one is how much will it cost them out of their pocket and that usually depends on their insurance coverage or possibly income level if the drug company has such programs for the drug of interest. I am a big supporter of President Trump but I don't see this having much impact on drug prices.