Coming soon: An FDA policy on CBD?
The FDA is about to release a long-awaited enforcement policy on cannabidiol, the marijauna-adjacent compound it has struggled to regulate for years.
The policy is going through the formal White House vetting process now, according to a White House website. And while the FDA hasn’t released virtually any specifics about the guidance beyond its title, “Cannabidiol Enforcement Policy; Draft Guidance for Industry,” it’s already getting outsized attention.
The CBD industry wants clear rules of the road for how to sell its products, as do its congressional allies. But the FDA, which still considers CBD products illegal, has been incredibly skittish about setting any such policies. It’s even vehemently denied that it currently uses a policy of “enforcement discretion” and only going after companies flagrantly violating the law, despite the fact that the FDA has essentially used that policy for more than a year.
That lack of clarity has led some industry lawyers to insist that even a formal codification of FDA’s existing policy would be a major step forward for industry.
“The FDA has adopted a de facto enforcement policy without actually adopting an enforcement policy,” said Jonathan Havens, a partner at Saul Ewing Arnstein & Lehr.
Havens insisted that FDA formalizing the policy would show investors and retailers that the FDA feels so confident that it can safely use enforcement discretion that it was able to release a formal policy on the topic that was vetted by the White House.
In the past weeks, the White House held a series of meetings with industry groups like the National Industrial Hemp Council and Ziese Farms.
Jonathan Miller, the general counsel for the U.S. Hemp Roundtable, which represents a number of the top CBD-makers in Washington and which also sent representatives, told STAT he pitched the White House on the importance of the FDA creating a formal enforcement discretion policy or a kind of safe harbor that would allow the CBD industry to sell their products legally.
The White House is set to meet with the American Herbal Products Association and the law firm WassermanRowe later this week.
The policy is going through the formal White House vetting process now, according to a White House website. And while the FDA hasn’t released virtually any specifics about the guidance beyond its title, “Cannabidiol Enforcement Policy; Draft Guidance for Industry,” it’s already getting outsized attention.
The CBD industry wants clear rules of the road for how to sell its products, as do its congressional allies. But the FDA, which still considers CBD products illegal, has been incredibly skittish about setting any such policies. It’s even vehemently denied that it currently uses a policy of “enforcement discretion” and only going after companies flagrantly violating the law, despite the fact that the FDA has essentially used that policy for more than a year.
That lack of clarity has led some industry lawyers to insist that even a formal codification of FDA’s existing policy would be a major step forward for industry.
“The FDA has adopted a de facto enforcement policy without actually adopting an enforcement policy,” said Jonathan Havens, a partner at Saul Ewing Arnstein & Lehr.
Havens insisted that FDA formalizing the policy would show investors and retailers that the FDA feels so confident that it can safely use enforcement discretion that it was able to release a formal policy on the topic that was vetted by the White House.
In the past weeks, the White House held a series of meetings with industry groups like the National Industrial Hemp Council and Ziese Farms.
Jonathan Miller, the general counsel for the U.S. Hemp Roundtable, which represents a number of the top CBD-makers in Washington and which also sent representatives, told STAT he pitched the White House on the importance of the FDA creating a formal enforcement discretion policy or a kind of safe harbor that would allow the CBD industry to sell their products legally.
The White House is set to meet with the American Herbal Products Association and the law firm WassermanRowe later this week.
Here comes the rebate rule food fight, part deux
The Campaign for Sustainable Rx Pricing, a coalition that includes the major lobbies for insurers, hospitals and middlemen, announced Tuesday a new advertising campaign criticizing the Trump administration's renewed push to end the system of drug rebates negotiated by drug makers and middlemen.
The ads come on the heels of a similar campaign launched last week by the Pharmaceutical Care Management Association. Both sets of ads, which direct viewers to call the White House, are the clearest sign yet that defenders of drug rebates are putting serious muscle behind efforts to make Trump’s stance a liability going into the November election.
“President Trump wants to reward big pharma’s price hikes,” the ad from CSRxP states. “Tell President Trump to stop the rebate rule now."
“The Trump administration just announced a plan to raise Medicare premiums and out of pocket costs for seniors, during a pandemic, just before an election,” the PCMA ad states.
CSRxP is planning a “significant six-figure campaign,” according to a spokesperson. The ad will run in Washington DC and in the battleground states of Arizona, Colorado, Florida, Iowa, Maine, Michigan, North Carolina, and Wisconsin through the GOP convention. PCMA didn’t detail its buy.
It’s official: Drug makers owe the government lots of missing data
The federal government is now warning pharmaceutical companies, device makers and universities that they have to publish missing clinical trials data “as soon as possible” — a major win for transparency advocates. It comes after a federal court ruled in February that the agency has to collect the missing data; the federal government declined to appeal that decision. For more, check out my colleague Lev Facher’s story, here.
Is Gilead sitting on a potentially more effective, albeit less lucrative, Covid-19 drug?
Yes, according to a pair of researchers at MD Anderson and the advocacy group Public Citizen. The groups are out with a new open letter attempting to pressure Gilead into studying another compound in the company’s portfolio, GS-441524, that they believe might be effective in treating coronavirus — and potentially more effective and easier to manufacture than the company’s approved product, remdesivir.
The authors claim that lab tests show the compound, is “similar or superior" to remdesivir and more easily synthesized. They also imply that that the company is uninterested in commercializing the drug because it has a shorter patent life than remdesivir.
“It is unclear why Gilead and federal scientists have not been pursuing GS-441524 as aggressively as remdesivir, but we cannot help but note that there are significant financial incentives tied to Gilead’s current patent holdings,” the letter states. “Gilead’s monopoly power over remdesivir may have at least five additional years of enforceability beyond that of GS-441524.”
For more, STAT’s Ed Silverman has the details here.
Are drug costs going up? It depends
Despite widespread anger over rising drug prices, consumers with insurance are being asked to pay less and less at the pharmacy counter, according to a new study from the group IQVIA. The average consumer with insurance is shelling out just $8.90 per prescription, down from the $10.83 they paid per prescription in 2015, Ed Silverman reports.
The situation is much different, however, for those paying cash: The uninsured are now spending an average of $50.78 per month per prescription, which is up from $36.77 in 2015.
The study underscores how much more complex drug pricing policy is than a simple soundbite can convey, and it shows that consumers’ exposure to high drug prices is largely dependent on the quality of their insurance. More here from Ed.
Are drug costs going up? It depends
Despite widespread anger over rising drug prices, consumers with insurance are being asked to pay less and less at the pharmacy counter, according to a new study from the group IQVIA. The average consumer with insurance is shelling out just $8.90 per prescription, down from the $10.83 they paid per prescription in 2015, Ed Silverman reports.
The situation is much different, however, for those paying cash: The uninsured are now spending an average of $50.78 per month per prescription, which is up from $36.77 in 2015.
The study underscores how much more complex drug pricing policy is than a simple soundbite can convey, and it shows that consumers’ exposure to high drug prices is largely dependent on the quality of their insurance. More here from Ed.
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