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The FDA’s panel of outside vaccine experts will meet Thursday to discuss approval standards for an eventual Covid-19 vaccine. These meetings are typically attended only by the nerdiest biotech investors and FDA lawyers, but this one is expected to attract so much attention that the FDA is setting up a Youtube stream for the event instead of its typical (often rage-inducing) internal streaming service.
The meeting won’t discuss individual vaccines. Instead it’ll be about the FDA’s approval standards, additional studies the FDA might require of vaccine makers and what type of follow-up should be required to monitor the safety of any vaccine that’s either fully FDA approved or authorized for emergency use.
A number of vaccine makers, doctors groups, and advocates are already flooding the FDA with other suggested topics to discuss. They include:
- How drug makers should manage their ongoing studies in the event their vaccine is granted emergency authorization. Pfizer, Johnson & Johnson, the Biotechnology Innovation Organization and the Infectious Diseases Society of America all raised a version of this concern in their comments. Their concerns seem to stem from a line in the FDA’s recent guidance that suggests the agency will require drug makers to continue to collect placebo-controlled data, even if their vaccine is authorized for emergency use. The groups argue that in that scenario, drug makers would have an ethical obligation to tell their study participants whether they were receiving a placebo.
- How the FDA would decide to issue an emergency authorization for a select high-risk group, like health care workers. Johnson & Johnson raised this question in their comments.
- Why isn’t the FDA conducting inspections of vaccine plants before authorizing a vaccine? IDSA wants the answer to that question.
- Why hasn’t Emily Miller been fired? This one isn’t your typical question for an expert panel, but that’s the question posed by the activist coalition Treatment Action Group. “The agency can restore public trust by improving transparency and communications, and by removing staff who’ve been involved in perpetrating political interference. Emily Miller, who was briefly and disastrously appointed FDA spokesperson and continues to post misinformation on COVID-19 therapeutics, should not be an agency employee,” the group wrote.
STAT’s Helen Branswell has more on the stakes of Thursday’s meeting here.
The fight between drug middlemen and pharmacists heats up
STAT loves drug pricing billboards: So our eyebrows shot up when we caught wind of this splashy new ad accusing independent pharmacies of making drugs more expensive. The billboard says it’s paid for by Texans for Affordable Rx. That campaign, it turns out, is paid for by the Pharmaceutical Care Management Association, the lobby for drug middlemen. It’s unclear if PCMA is running the campaign nationwide, but with some sleuthing, STAT was able to uncover similar campaigns in Illinois, Michigan, Pennsylvania, Georgia, Florida, North Carolina, Maryland, Oklahoma and Wisconsin.
The campaign is perhaps the most aggressive to date from PCMA, which has been battered with criticisms from both drug makers and independent pharmacies for years.
Most of the campaign’s websites slam independent pharmacies, which have accused middlemen of cutting their reimbursement and pushing them out of business. Many websites suggest pharmacists are making six-figure salaries, and imply that therefore, independents are “doing just fine.”
These websites also include some interesting state-specific “flavor,” like this gem from PCMA’s Wisconsin website: “There’s a term folks use to describe Wisconsinites: Midwest Nice. What does that mean? Well, it means that if you run out of brats during a Packers tailgate at Lambeau, there’s always somebody close by with one or two to share. It means you’ll always get a wave from passing boats when you’re fishing out on Lake Winnebago. And more than anything else, it means you can always rely on your neighbors to watch out for you. We embrace that Wisconsinite sentiment – and when it comes to prescription drug costs we’re watching out for you, too.”
In a statement, PCMA said the campaign was meant to educate policymakers and consumers about drug prices and “the real motivations behind special interest groups in the prescription drug supply chain – specifically the costly independent pharmacy lobby agenda.” The group did not answer STAT’s questions about where PCMA was running campaigns and how much money the campaign cost.
State health officials: To fight Covid-19, we need money
Public health departments have submitted their Covid-19 vaccination plans to the Centers for Disease Control and Prevention, but they insist the ideas can’t truly be implemented unless they get more federal funding.
“It’s one thing to write a strong plan; it’s quite another to implement the plan,” Claire Hannan, the executive director of the Association of Immunization Managers, said Monday on a call with reporters. Without funding, she said, the vaccination plans states have submitted to the CDC for review amount to just “wish lists.”
The Association of State and Territorial Health Officials has been calling on Congress to greenlight more than $8 billion in funding for vaccine distribution and administration. That’d go toward hiring people who can give the shots, building IT systems to track who has received a dose and when people need to get their second dose, and supporting all the logistics, storage, and transportation of the vaccines.
The state health leaders also stressed the need to fund an effective communications campaign to spread the word about the vaccines when they are available and to convince people that the immunizations are safe and effective, what’s increasingly looking like an uphill challenge.
Pharma’s support for GOP attorneys general could backfire
Obamacare, generally, has benefited the drug industry. So why is pharma giving so much money to the Republican attorneys general who want to repeal it? STAT’s Ed Silverman explores that question in a new story this morning.
Drug makers gave $1.6 million last election cycle to the Republican Attorneys General Association. The lion’s share of those donations went to Texas AG Ken Paxton, the lead plaintiff in Texas v. California, the lawsuit challenging the Affordable Care Act, which will be heard by the Supreme Court Nov. 10.
Drug makers insist that they donate to both Democrats and Republicans and typically do not specify how their donations be used, but one government accountability expert told STAT the donations show “companies don’t pay attention to the consequences of their spending.”
The drug industry’s influence in state politics
A new exclusive analysis conducted by STAT and the National Institutes on Money in Politics finds that more than one-quarter of all state lawmakers nationwide have already accepted money from the pharmaceutical industry since the start of 2019, and that drug makers have poured more than $5 million into state political races over the same time frame.
While the spending pales in comparison to how much drug makers typically spend on a federal level, their spending is often much more impactful on a state level. And if you’ve been following drug pricing long, you know that much of the action happens in the states — from first-of-their-kind insulin affordability programs to prescription drug affordability boards.