Raphael Stevens

Every weekday the CNBC Investing Club with Jim Cramer holds a “Morning Meeting” livestream at 10:20 a.m. ET. Here’s a recap of Tuesday’s key moments. Buy JNJ while it’s down Look to buy Danaher Wait to buy AMD 1. Buy JNJ while it’s down Shares of Johnson & Johnson (JNJ) slipped more than 1% Tuesday after the drug maker delivered a beat on fourth-quarter profit but missed on revenue estimates. The stock doesn’t deserve to go down, especially considering that the company’s 2023 earnings outlook came in higher than expected . J & J’s only real weakness for the quarter came in its medical technology segment, which was held back by Covid-19 lockdowns in China. The declines are indicative of a broader trend of investors moving out of health-care names this year, in a reversal from 2022. That’s a shift we don’t support. Instead, we urge investors to buy shares of this high-quality company while it’s out of favor. 2. Look to buy Danaher Danaher (DHR) on Tuesday reported strong fourth-quarter earnings but forecasted a lighter-than-expected guidance, sending the stock down nearly 3% in midmorning trading. The company had preannounced the quarter, so the earnings beat was already baked into the stock. Danaher, whose operations include life sciences, diagnostics and environmental solutions, continues to expect its core revenue to grow by a high-single-digit percentage point this year. We remain bullish on the stock. Investors should buy shares of Danaher if the stock falls further today, by at least 5%. 3. Wait to buy AMD Bernstein on Tuesday downgraded Advanced Micro Devices (AMD) to market perform, or neutral, from outperform, citing concerns over a deteriorating PC market. That comes a day after Barclays upgraded the semiconductor maker to overweight, or buy, from equal weight. Amid the competing calls, we advise investors to wait on buying AMD, as the stock will likely be battered further in the coming months. (Jim Cramer’s Charitable Trust is long AMD, JNJ, DHR. See here for a full list of the stocks.) As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust’s portfolio. If Jim has talked about a stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB. NO SPECIFIC OUTCOME OR PROFIT IS GUARANTEED. More

Chewy’s Connect With a Vet allows customers to virtually talk with licensed veterinarians and technicians, but regulations prevent them from diagnosing conditions or prescribing medications.
There’s a growing movement to change those regulations, spearheaded by a noncharitable nonprofit that was co-founded by a lobbyist and is funded in part by Chewy.
Several longtime veterinarians expressed their skepticism about Connect With a Vet, saying it could potentially be harmful to pets.

The Chewy.com application is displayed in the on an Apple iPhone.
Andrew Harrer | Bloomberg | Getty Images

Chewy, the e-commerce pet-goods giant best known for its convenient auto-ship services and generous return policies, wants to grow its veterinary telehealth service as part of an overall push into health care. 
While the telehealth service is a small part of the company’s rapidly expanding health offerings, it is important to its strategy. Yet it also faces regulatory obstacles and skepticism from the veterinary community. Longtime veterinarians told CNBC the service can have some benefit for minor situations, or for people who don’t have easy access to vet care. But it could create problems for pets, too, they said.

Chewy’s service, called Connect With a Vet, has experienced significant growth, but it’s been limited by a specific kind of regulation known as the veterinary client patient relationship, or VCPR, according to Chewy CEO Sumit Singh. 
“If you look at our Connect With a Vet, it’s the singular most scaled telehealth platform in the market today, only after two years, and yet, it doesn’t form a meaningful portion of our business. Why? Because when you research pet health, you’ll find that there’s a specific term called VCPR,” Singh said.
He also noted that barrier is “breaking down” in the wake of the Covid pandemic and multiple states “are already doing away with VCPR.”

Arrows pointing outwards

Chewy Connect with a Vet service.

Most states forbid veterinarians from performing their primary duties – diagnosing conditions and prescribing medication – until they establish a VCPR by seeing an animal in-person and performing a physical exam. 
“Trying to make an assessment over video without any prior relationship at all, that’s the part that kind of concerns me,” said Brett Levitzke, the chief medical officer and founder of Veterinary Emergency and Referral Group, an emergency animal hospital in New York City. “There is no substitute for a physical exam. Period.” 

Nonetheless, there is a growing movement to change VCPR regulations. The leader behind that push, the Veterinary Virtual Care Association, or VVCA, is an advocacy group co-founded by longtime lobbyist and political strategist Mark Cushing. It’s funded by Chewy and several other pet businesses expanding into vet telehealth. 
When asked about the company’s position on VCPR, Chewy said it doesn’t take a stance on the issue and declined to say whether its veterinarians would diagnose and prescribe medication if the laws are changed. Currently, Chewy’s veterinarians do not diagnose conditions or prescribe medications.
The company suggested CNBC speak with Cushing, whom the company described as an industry expert on the matter, to learn more about VCPR. Cushing said he does not represent Chewy “in the telemedicine space,” but the company is a primary sponsor of the VVCA. 
It is not clear how much money Chewy has donated to the VVCA because, as a noncharitable nonprofit, it’s not required to disclose donor information to the public. Cushing is also the CEO of the Animal Policy Group, a lobbying organization, which has advocated on behalf of Banfield Pet Hospital, a network of clinics that offer in-clinic services and veterinary telehealth, according to lobbying reports filed with the U.S. Senate. Banfield Pet Hospital is owned by Mars Veterinary Health, a subsidiary of pet food and candy conglomerate Mars. 
The goal of the VVCA is to make veterinary telemedicine legal across the country so vets can diagnose conditions and prescribe medications virtually at their own discretion – even if they’ve never laid hands on the animal. 
“The hardest thing, though, the most expensive thing in telemedicine in the veterinary space, by far, is customer acquisition,” said Cushing.
Prescribing medication and diagnosing conditions without ever performing a physical exam on an animal poses “massive risks” that could ultimately be harmful, or even fatal in some rare instances, Dr. Linda Isaacson, who has been a veterinarian since 2003 and runs three clinics in Brooklyn, told CNBC.
Sometimes, for instance, a pet owner may say their animal is constipated, but a physical exam will reveal a urinary blockage, Isaacson said.
“A urinary blockage is life threatening, you know, if they don’t urinate, they’ll die and you wouldn’t be able to tell that from telemedicine,” she said. “So, if you’re going on telemedicine and they’re just prescribing, you know, a laxative, that’s not going to help that pet, right? They’ll be dead.”

Chewy pushes into health

Chewy was co-founded in 2011 by Ryan Cohen, an activist investor and the current chairman of GameStop. He left the company in 2018 and the following year, Chewy went public at a valuation of $8.8 billion. Chewy’s market value currently sits around $18.5 billion.
Under Singh’s leadership as CEO, Chewy’s annual revenue soared from $3.53 billion in fiscal 2018 to $8.9 billion in fiscal 2021, but the company has been stymied by repeated annual net losses and slim margins. 
During a sitdown interview with CNBC earlier this month, the former Amazon executive said expanding pet health and wellness, which are higher-margin categories than pet food, will be essential to getting the company on a path to profitability. 

Chewy CEO Sumit Singh is interviewed on CNBC during the Chewy IPO at the New York Stock Exchange, June 14, 2019.
Andrew Kelly | Reuters

It’s a strategy that Chewy’s main competitor outside of big-box retailers, Petco, has undertaken as well. It rebranded as a health and wellness company in 2020. Petco has veterinarians on its payroll working inside of full service hospitals and clinics built inside stores. When asked, Petco said telehealth isn’t off the table, but for now, its focus is “hands on pets,” which is what they say pet parents want.
Chewy’s expansion into health – including insurance, prescription food and medication – came as the pandemic-fueled pet boom saw 23 million American households welcome a new animal into their homes, turning the overall pet industry into a $123.6 billion market in 2021, according to data from the ASPCA and the American Pet Products Association.
Chewy aims to make health care about 30% of its overall business in the coming years, according to Singh. The company wouldn’t say how much pet health care accounts for in its current revenue stream, but less than 5% of Chewy’s customer base buys their health products from the company.
“If you notice, there has been little to no innovation in pet health over the last decade, and yet in the last three years, there’s been more innovation in pet health than in the last decade or 20 years,” Singh said.

The tricky nature of pet telehealth

The sudden surge of new animal owners during the pandemic made it difficult to book vet appointments, and it put a strain on an already understaffed and burnt out veterinary community. The rules around establishing a VCPR virtually without a physical exam were relaxed in some states out of emergency need.
Outside of an emergency like a global pandemic, the American Veterinary Medical Association, the nation’s leading advocacy group for veterinarians, maintains that a VCPR can only be established after an in-person exam. The group’s ethical standards allow vets to diagnose, prescribe medication or treat animals virtually – but only after a VCPR has been established in-person. 
“Without a VCPR, any advice provided through electronic means should be general and not specific to a patient, diagnosis or treatment,” the AVMA advises in its guidelines on telemedicine.
Despite the AMVA’s stance, at least five states – Michigan, Oklahoma, Indiana, Virginia and New Jersey – have made the lighter rules permanent, according to the VVCA.
Chewy said it considers Connect With a Vet a tele-triage platform, not a replacement for in-clinic care, where customers can be connected with a licensed doctor or technician and ask them about their pet’s health concerns, diet, behavior and products that can increase “lifelong wellbeing.” 

A dog hi-fives it’s owner in front of the New York Stock Exchange (NYSE) during Chewy Inc.’s initial public offering (IPO) in New York, U.S., on Friday, June 14, 2019.
Michael Nagle | Getty Images

Chewy said the program was created to make vet care more affordable and accessible to everyone. The service is designed to help clients access some form of care when they can’t book an immediate appointment, can’t afford one or don’t live close to an in-person clinic, the company said.
Connect With a Vet is also intended to help pet parents figure out if an issue their pet is having is an emergency that requires immediate care or something they could handle down the line during an in-person veterinarian appointment. The company warns customers to go to the closest veterinary clinic if their animals are experiencing a life-threatening situation. Other companies offer similar services.
Chewy has also started a B2B offering called Practice Hub, which creates a marketplace for veterinary clinics to sell their products to clients within Chewy.com. The service is currently free for veterinarians, and they get a portion of the revenue when their clients place orders on Chewy for products offered by the clinic. In return, Chewy gets access to their clients. This month, the platform will have 1,500 clinics, Chewy said.

Veterinarians weigh in

Isaacson, the Brooklyn vet, used telehealth during the height of the pandemic. She said about 50% of clients needed to bring their pet to the clinic after virtual sessions. 
“It’s very hard to hold the pet still. I can’t really even see anything usually over the video. I think it works better for human medicine, but for animals, you know, it wasn’t ideal,” Isaacson said. “It’s not like a person that can tell you how they’re feeling or sit still or show you something.”
Isaacson no longer offers the virtual service. And she is concerned new pet parents might consider Chewy’s service and others like it a replacement for traditional, industry standard veterinary care.
“You think if it’s allowed, then it’s safe, right?” said Isaacson. “It’s not, it’s substandard care.”
On the web page for Chewy’s Connect With a Vet service, the company advertises a sample conversation between a Chewy doctor and a client whose animal had started limping. It’s a condition that could be serious and can only be managed after a physical exam if there’s no prior relationship with the pet, according to Levitzke, of Veterinary Emergency and Referral Group. 
“Are they limping because they have an overall sense of weakness? Are they limping because their knee hurts? Are they limping because they can’t feel their leg at all? Those are all three drastically different scenarios that are all possible,” said Levitzke. 
Chewy offered to make one of the veterinarians using its Practice Hub service available to CNBC for an interview. The company suggested Audrey Wystrach, who is the co-CEO of Petfolk and a co-founder of the VVCA, the nonprofit Chewy funds.
Wystrach has been a veterinarian for 28 years and practices telehealth. She also practices full-on telemedicine, where she can prescribe and diagnose virtually, but only with clients she has an existing relationship with.
She believes veterinarians should have more discretion to practice the medicine they’re licensed for and should be able to establish a VCPR virtually, if they determine it’s safe.
“You know, it is not a good idea to work on a pet that can’t breathe in a virtual space, that’s a pretty big no brainer,” said Wystrach. “But is it okay for me to, you know, be able to look at a pet’s mouth and see if they have a fractured tooth or talk to somebody about behavior or nutrition? Or even skin?”
She said the demand for veterinarians outpaces the supply, and veterinary telehealth and medicine is crucial to ensure pet parents can get access to care.
“I’ve always had the mantra that says, virtual care is better than no care,” she said. “I think we got to get to where we’ve got a realistic outlook on how we’re going to manage the sheer volume of pets that are under the care of people in today’s day and age.”
Clarification: This story was updated to clarify the functions of Chewy’s Practice Hub.

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Smart Tax Planning

If you’re expecting a refund this season, you may avoid processing delays by filing a complete and accurate return, according to the IRS.
Before filing, it’s critical to get organized with your tax forms to report activity such as income, deductions and credits.
As a starting point, experts suggest reviewing last year’s tax return “page-by-page” to make a checklist of the forms you’ll need.

If you’re expecting a refund this season, it’s critical to file a complete and accurate tax return to avoid “extensive processing” and delays, according to the IRS.   
One of the keys to error-free filing is including all your required tax forms, known as information returns, which employers and financial institutions send yearly, with copies going to the IRS and taxpayer.

If you skip tax forms received by the agency, the IRS systems may flag your return and mail you a notice, explained Sheneya Wilson, a certified public accountant and founder of Fola Financial in New York.
More from Personal Finance:Tax season opens for individual filers Jan. 23, says IRSNearly one-third of Americans will rely on tax refunds, survey findsWhat to know about the 1099-K tax reporting change for Venmo, PayPal
“Missing tax documents are definitely going to cause a refund delay,” Wilson said. 
Whether you’re working with a tax professional or filing on your own, here’s what to know about your tax forms — and when to expect them.

When to expect your tax forms

While most tax forms have a Jan. 31 deadline, others aren’t due until mid-February or beyond, said certified financial planner John Loyd, owner at The Wealth Planner in Fort Worth, Texas. 

For example, the deadline for 1099-B for capital gains and losses and 1099-DIV for dividends and distributions is Feb. 15. But some investment firms get an extension from the IRS for more time to validate forms and avoid corrections, meaning you may not receive these forms until March, Loyd said. 

If you do need a corrected form, it can slow down your filing process because it takes time for the investment firm to update and reissue your documents, he said.
Regardless of your situation, it’s important to have all the necessary forms handy before filing your return, Loyd said. “It’s 1,000 times better” to file correctly the first time, he added, noting that IRS notices may take months to resolve.

Review last year’s return ‘page-by-page’

If you’re not sure which tax forms to expect, experts say last year’s tax return is a great starting point.
“I go page-by-page with the prior year and current year’s [returns],” said Marianela Collado, a CFP and CEO of Tobias Financial Advisors in Plantation, Florida. She is also a CPA. “That’s always a good check,” she said.
For earnings, some of the common forms include a W-2 for wages, 1099-NEC for contract or gig economy work, 1099-G for unemployment income and 1099-R for retirement plan distributions. 
For 2022, you probably won’t receive a 1099-K for payment apps such as Vemno or PayPal unless there were more than 200 payments worth an aggregate above $20,000. If you receive this form by mistake, the IRS said, it is working on guidance.

Of course, it’s also important to make sure the numbers on your tax return match those on your 1099s because “that’s something that could trigger a delay,” Collado said.   
As for tax breaks, you may need forms 1098 for mortgage interest, 5498 for individual retirement account deposits, 5498-SA for health savings account contributions, 1098-T for tuition, 1098-E for student loan interest and more. More

British supermarket chain Tesco has warned that some food producers may be taking advantage of inflationary pressures, raising prices more than necessary.
Chairman John Allan said it was “entirely possible” that some food firms are profiteering from inflation at the cost of some of the poorest consumers.
But consumer group Which? has said supermarkets may be passing the buck, as the price of their own label foods rose at a greater rate than that of branded products in the last quarter.

Consumers have been feeling the pinch from higher food prices as inflation soars.
Nathan Stirk | Getty Images News | Getty Images

As inflation continues to push up grocery bills, supermarket chain Tesco has warned that some food producers may be taking advantage of the situation by raising prices more than necessary.
The chairman of Tesco, one of Britain’s largest supermarket chains, said Sunday it was “entirely possible” that some food firms are profiteering from inflation at the cost of some of the poorest consumers.

John Allan told the BBC that Tesco had “fallen out” with “a number of suppliers,” following discussions over price hikes that the supermarket had challenged.
Tesco has created a team to monitor food input costs against price rises and is challenging companies it believes are lifting prices disproportionately, Allen said.
“We have a team who can look at the composition of food, costs of commodities, and work out whether or not these cost increases are legitimate,” he told the “Sunday with Laura Kuenssberg” program.
Allan said that, while most price hikes were legitimate, the supermarket was “trying hard to challenge” those it deemed were not.
Tesco told CNBC that it was unable to provide further comment.

Food suppliers have hit back at the claims. Heinz beans and tomato ketchup were among the products that Tesco temporarily removed from shelves last year in a pricing dispute. The products returned to sale after an agreement was reached.
A spokesperson for Kraft Heinz told CNBC Monday that the company continues to face increased production costs and rising inflation, but is “absorbing costs” where possible.

Passing the buck

A consumer group called Which? said that it was possible that supermarkets like Tesco were passing the buck by claiming that suppliers were raising prices unfairly.
In its latest Supermarket Inflation Tracker, Which? found that branded items had a lower inflation rate than that of supermarkets’ own label items. In the three months to December 2022, the prices of stores’ own label items rose 18.3% year-on-year, compared to a 12.3% year-on-year hike for branded items.
“We’ve seen huge price increases at the supermarket with our research showing that despite more people opting for own-brands and basic products to help them through the cost of living, these ranges have been subject to higher rates of inflation than premium and branded foods,” Reena Sewraz, Which? retail editor, told CNBC.
It comes as consumers continue to face higher prices, as a result of supply chain disruptions and Russia’s war in Ukraine.

U.K. inflation dipped slightly to 10.5% in December from 10.7% in November, but remains at a 40-year-high.
The price of food and non-alcoholic beverages rose 16.9% in the year to November 2022, new data showed Wednesday.
These price hikes have prompted more shoppers to opt for supermarket branded items and discount chains, such as Lidl and Aldi.
Discount supermarkets are not immune to the recent cost increases. While they remain among the U.K.’s cheapest supermarkets, prices at Lidl and Aldi respectively rose 21.1% and 20.8% in the year to December, according to Which?.

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SpaceX announced on Monday it completed a major test of its latest Starship prototype.
Starship prototype 24, stacked on Super Heavy booster prototype 7, was fueled up at SpaceX’s Starbase facility in Texas in a test known as a “wet dress rehearsal.”
An orbital launch attempt of Starship marks the next step in flight testing for the rocket.

Starship prototype 24 stacked on top of Super Heavy booster prototype 7 at the company’s facility near Brownsville, Texas on January 9, 2023.

SpaceX announced on Monday it completed a major test of its latest Starship prototype, as the company prepares for the first orbital launch of the towering rocket.
Starship prototype 24, stacked on Super Heavy booster prototype 7, was fueled up at SpaceX’s Starbase facility in Texas in a test known as a “wet dress rehearsal.” While the test does not include firing up the rocket’s engines, it is a typical practice during development of a new liquid-fueled vehicle to show that it can be safely filled before a launch, as well as verify the steps of a launch countdown.

“This was the first time an integrated Ship and Booster were fully loaded with more than 10 million pounds of propellant,” SpaceX said in a tweet.
Starship is a nearly 400-foot-tall rocket, designed to carry cargo and people beyond Earth. It is also critical to NASA’s plan to return astronauts to the moon, with SpaceX having won a nearly $3 billion contract from the agency in 2021.

Sign up here to receive weekly editions of CNBC’s Investing in Space newsletter.

An orbital launch attempt of Starship marks the next step in flight testing for the rocket. It’s been nearly two years since the company last performed a Starship flight test, and late last year SpaceX shook up leadership at its “Starbase” facility in Texas as the company pushes to get the next launch off the ground.
SpaceX has a few more steps remaining before Starship can next launch, including a planned test firing of all 33 engines at the base of the Super Heavy rocket booster. The company also needs a launch license from the Federal Aviation Administration.

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Anti-abortion physicians are suing to overturn the FDA’s approval of mifepristone, which dates back more than two decades.
Mifepristone used in combination with misoprostol is the most common way to terminate a pregnancy in the U.S.
If the lawsuit prevails, mifepristone would no longer be available in the U.S. market and the FDA’s drug approval powers would be weakened.

Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medication abortion, are seen at the Women’s Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.
Robyn Beck | AFP | Getty Images

The Food and Drug Administration is squaring off with anti-abortion physicians in an unprecedented legal challenge to its more than two-decade-old approval of a pill used to terminate early pregnancies.
The Alliance for Hippocratic Medicine asked a federal district court in Dallas late last year to declare the FDA approval unlawful and completely remove the abortion pill from the U.S. market.

The case has thrust the FDA in the middle of the fierce national battle over abortion access in the wake of the Supreme Court’s decision to overturn Roe v. Wade last June. If the lawsuit prevails, women across the U.S. would lose access, at least temporarily, to the most commonly used abortion method. The FDA’s powers to approve drugs would also be weakened.
The court could issue a ruling as soon as Feb. 10 when it will be fully briefed.
The Alliance for Hippocratic Medicine is represented by the Alliance Defending Freedom, a Christian organization that played a central role in the Dobbs vs. Jackson Women’s Health Organization case that ultimately resulted in the Supreme Court abolishing federal abortion rights.
Judge Matthew Kacsmaryk is hearing the challenge to the FDA’s approval of the abortion pill. Kacsmaryk was appointed by former President Donald Trump to the U.S. District Court for the Northern District of Texas in 2019.
If the alliance wins in federal district court, the Biden administration would appeal to the 5th Circuit in New Orleans, a conservative court with 12 of its 16 active judges appointed by Republicans. From there, the case could end up at the Supreme Court.

The FDA approved mifepristone in 2000 for use in combination with misoprostol as a safe and effective way to end early pregnancies. The drug regimen is currently approved for use up to the 10th week of pregnancy. Half of abortions in the U.S. are performed with mifepristone and misoprostol.

‘Extraordinary and unprecedented’

In their complaint, the anti-abortion physicians argue the FDA abused its power by approving mifepristone through an accelerated process which is reserved for new drugs that would benefit patients with serious or life-threatening illnesses more than what’s currently available.
They contend pregnancy is not an illness, mifepristone is not more safe and effective than surgical abortion, and claim the FDA’s actions have put patients’ health at risk.
The FDA, in its response filed earlier this month, described the lawsuit as “extraordinary and unprecedented.” The government’s lawyers said they could not find any previous example of a court second-guessing an FDA approval and removing a widely available drug from the market.
The FDA determined that mifepristone is a safe and effective way to end an early pregnancy more than two decades ago based on extensive scientific evidence, the agency’s lawyers wrote. Decades of experience from thousands of women and their physicians has confirmed mifepristone is safer than surgical abortion or childbirth, they said.

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The public interest would be “dramatically harmed” by pulling mifepristone from the market, the government lawyers argued. It would put more women’s health at risk and cause overcrowding and delays at clinics that provide surgical abortion, they wrote in their response.
A decision by the court to overturn the FDA’s approval could also harm future drug development, the government’s lawyers said.
“If longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions,” the Biden administration lawyers wrote.
Lawrence Gostin, an expert on public health law at Georgetown Law, said it would be “highly irresponsible” and “reckless” for a judge to overturn the FDA approval of mifepristone. It would have “disastrous” consequences and set a “cataclysmic” precedent, he said.
“You can’t have individual states let alone a single judge overturning all of the scientific evidence that’s assessed by the federal Food and Drug Administration and usurping that power for itself,” said Gostin, who has advised the Biden administration in the past on health policy.
“It would mean that any FDA regulatory or approval decision could be subject to the whims of a single federal court or state,” Gostin said.

Standing and statute of limitations

The federal government has argued that the medical associations and individual physicians who filed the lawsuit do not have standing because their claims of harm are speculative.
Two obstetricians, an emergency department doctor and a family physician claim in the lawsuit that they’ve treated patients who have had complications from “chemical abortions.” The medical associations claim they spent resources petitioning the FDA over its regulatory actions on mifepristone.
Standing aside, the federal government has also contended that the statute of limitations bars the plaintiffs from challenging the FDA’s 2000 approval of mifepristone. Under federal law, lawsuits against the U.S. government must be filed within six years of an agency action.
The Alliance for Hippocratic Medicine, however, has also asked the court to overturn a number of more recent FDA actions on mifepristone. These include the agency’s 2019 approval of a generic version of the pill and its 2021 decision to allow delivery of the medication by mail.
The alliance argues that the delivery of abortion pills violates a federal statute from 1873 known as the Comstock Act, which declares anything designed or intended to produce an abortion as nonmailable.
But the Justice Department, in an opinion issued in late December, said the law does not prohibit the delivery of mifepristone and misoprostol when the sender does not intend to break the law.
“It’s giving the Post Office, the USPS, the legal ground that they feel they need to stand on to do what they’re doing — which is to continue to ship these medications,” Jennifer Piatt, an expert at Arizona State University’s Center for Public Health Law and Policy, said of the DOJ opinion.
It’s possible the judge could block these 2019 and 2021 actions by the FDA rather than completely withdraw mifepristone from the U.S. market. The federal government has argued that even an injunction which is more limited in scope “would unduly burden the public and healthcare systems.”
“Never say never,” Gostin said. “Some of these judges have proven to be real culture warriors. They do have the power to issue nationwide injunctions.”

FDA authority in post-Roe America

Regardless of the outcome in the Northern District of Texas, abolishing federal abortion rights has called into question just how far the FDA’s approval of new drugs extends in a post-Roe America.
The FDA earlier this month allowed retail pharmacies to dispense mifepristone for the first time if they get certified with the federal government and the patient has a prescription from a certified health-care provider.
CVS and Walgreens, the nation’s two largest drugstore chains, have said they are applying for certification and will provide the abortion pill in states where the law allows. But a dozen states have banned abortion in nearly all circumstances, and a number of others have restrictions on dispensing and administering mifepristone that conflict with FDA regulations.
The attorney general of Alabama recently suggested that women could be prosecuted for self-managing abortions with mifepristone. And Florida warned pharmacies in a letter last week that dispensing the abortion pill directly to patients is illegal under state law.
But the FDA’s powers stem from Congress’ constitutional authority to regulate interstate commerce. Lawmakers gave the agency the power to decide which drugs are introduced into the U.S. based on whether they are safe and effective. This raises the question of whether or not the FDA’s approval of mifepristone preempts state laws that ban it for abortions.
Pharmacies, however, are licensed by state boards. As a practical matter, this means states that have banned abortion have the power to revoke the licenses of pharmacies that dispense mifepristone in contravention of local law.
“For retail pharmacies that want to get into this space, they’re going to be looking at risk and the risk that they’re looking at is that they’re in a state with a full abortion ban,” Piatt said. “They’re not going to want to start immediately selling those items for fear of violating the state law.”
The courts have in the past ruled that FDA’s drug approval powers supersede state law. In 2014, Massachusetts tried to ban the painkiller Zohydro, which contains hydrocodone, after declaring a public health emergency in response to the opioid crisis. But a federal district court judge blocked the ban from taking effect, arguing Massachusetts was obstructing the FDA’s mandate from Congress.
“If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health,” Judge Ryan Zobel of the U.S. District Court for Massachusetts wrote.
Just how far the FDA’s authority extends into states with abortion bans that conflict with the agency’s decisions on mifepristone is a question which will be decided in federal courts in the months ahead, Piatt said.

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