Texas eyes abortion pills as ‘controlled’?

Jan 10, 2025

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With Carmen Paun

Driving The Day

Bottles of mifepristone and misoprostol are seen.

Some Texas lawmakers want to further limit access to the abortion pills mifepristone and misoprostol. | Charlie Neibergall/AP

PILLS FACE NEW RULES — When the Texas Legislature begins its session Tuesday, lawmakers will consider measures to further limit access to abortion pills — including one mirroring a new law in neighboring Louisiana deeming the medications controlled substances.

Three Republicans have prefiled bills that would make mifepristone and misoprostol — the two drugs prescribed for medication abortions in the U.S. — Schedule IV controlled substances. States may set drug penalties that differ from the federal system, applying looser or stricter punishments depending on their priorities and resources.

Reproductive rights advocates say such a move would erect more barriers for pregnant patients who need the drugs for miscarriage management and emergency treatment in states that already boast the country’s most restrictive abortion bans.

The designation “just creates needless delays and denials of care,” said Alex Moody, staff attorney at Lift Louisiana, a reproductive rights advocacy group that’s sued the state to challenge the law.

Texas Right to Life President Dr. John Seago said the status change is “a piece of the puzzle” to hampering the trend of pills being mailed to the state while legislators write “more robust legislation.”

“This is not a fight we went out looking for,” he said.

In practice: Health care providers must follow certain recordkeeping and storage requirements for controlled substances “even in the hospital setting,” said Anna Legreid Dopp, senior director of government relations at the American Society of Health-System Pharmacists. Locking the drugs away from a unit can delay their use in emergencies, she said.

Pharmacists must enter prescription and patient information into a monitoring system as they do for opioids, a requirement that could make some reluctant to dispense the drugs due to the information’s accessibility to law enforcement and other providers.

“There’s potential for this to create a kind of fishing expedition for miscarriage management,” said Rachel Rebouché, dean of Temple University’s Beasley School of Law.

The goal: One bill would shield pregnant people from criminal penalties for possessing the drugs for their own use. The Louisiana law contains a similar carveout.

Greer Donley, an abortion law expert at the University of Pittsburgh Law School, said it won’t stanch the flow of pills from states that shield abortion providers from liability regardless of where the patient lives.

“What they’re doing is legal in their state,” she said. “There’s just no evidence these laws are going to have any impact on abortion.”

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Our thoughts are with those impacted by the Los Angeles fires.

Send your tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

A message from AMAC Action:

The Inflation Reduction Act took billions from the Medicare Part D prescription drug program to fund electric vehicle tax credits and green energy investments, and now seniors’ prescription drug premiums are skyrocketing. Seniors are calling on Congress to pause the Inflation Reduction Act and return those funds back to Medicare where they belong. Visit PauseTheIRA.com.

Drug Pricing

A pharmacy.

List prices of some top drugs that weren't part of the first round of Medicare drug-pricing negotiations have doubled since they were introduced. | AP Photo/Mark Lennihan, File

AARP: TOP DRUGS’ LIST PRICE DOUBLED OVER LIFETIME — The 25 brand drugs with the most Medicare Part D spending not selected for the first round of government negotiations have had their list price increase an average of 98 percent over their lifetime, a new AARP analysis found.

The drugs — which include Ozempic, prostate cancer medicine Xtandi and breast cancer treatment Ibrance — represented almost $50 billion in Medicare Part D spending in 2022.

“These findings highlight the importance of provisions in the Inflation Reduction Act that allow the Medicare program to negotiate prescription drug prices and require drug companies to pay penalties when they increase their prices faster than the rate of inflation,” Leigh Purvis, prescription drug policy principal in AARP's Public Policy Institute, said in an accompanying commentary.

PhRMA spokesperson Sarah Ryan argued the report’s focus on list prices is an incomplete picture.

“This misleading report is tailored to fit their narrative by only focusing on the list price for a select number of medicines while not taking into account the significant rebates and discounts in the system that lower these prices,” Ryan said.

Others associated with the pharmaceutical industry said examining net prices would be a better measure.

“There have been large increases in list prices that have not been reflected in net prices,” said Brian Reid, principal at Reid Strategy, a consultancy that works with pharmaceutical companies, noting some drugs on the list have been on the market for more than a decade.

The IRA’s inflation penalties might constrain large increases in list prices, and many drugs on AARP’s list are likely to be among the 15 drugs selected for the next negotiation program before February, according to Reid.

MEDICAL DEVICES

COIN TOSS ON ADDICTION RISK — A genetic test the FDA approved a year ago to help doctors predict the risk of addiction in adults before prescribing opioids may not be any more effective than a coin toss, according to a new study.

Researchers at the University of Pennsylvania’s Perelman School of Medicine analyzed a diverse sample of nearly half a million people exposed to opioids, out of which nearly 34,000 had an opioid use disorder, POLITICO’s Carmen Paun reports. The results showed that the genetic variants the researchers say underpin the test were accurate in about 53 percent of the cases.

“It’s no better than chance,” Dr. Henry Kranzler, a psychiatry professor and the director of the Center for Studies of Addiction at the school, who led the study, told Prescription Pulse.

Why it matters: The use of the test could be harmful because it could hamper access to pain medication for people at low risk of addiction or give a false sense of security to those at high risk, Kranzler said.

Background: The test, AvertD by AutoGenomics, uses 15 genetic variants and machine learning to determine whether a patient who has never been prescribed opioids is at risk of developing addiction if they get opioid pain medication for up to 30 days to treat acute pain.

The information from the test shouldn’t be used alone but as part of a complete clinical evaluation and risk assessment, the FDA said at the time of its approval.

But Kranzler said tens of thousands of genetic variants could be in a person’s genome that can contribute to addiction, and the 15 the studies focus on aren’t sufficient to predict someone’s opioid addiction risk.

The FDA and AutoGenomics did not respond to a request for comment.

A message from AMAC Action:

Pharma Moves

Biogen appointed Adam Feire as head of business development and external innovation. He most recently worked in Novartis’ corporate and business development unit.

Royal Philips appointed Jie Xue to be chief business leader of its precision diagnosis unit. It also named Özlem Fidanci as chief of its international region unit.

The Alliance for a Stronger FDA announced Cartier Esham as its executive director. She previously worked as chief scientific officer for Biotechnology Innovation Organization and is CEO of Esham Strategies.

Document Drawer

A number of FDA domestic and foreign food facility inspections have not met targets since fiscal 2018, the Government Accountability Office found.

WHAT WE'RE READING

Dr. Shereef Elnahal wants to keep his job as undersecretary for health at the Department of Veterans Affairs, POLITICO’s Erin Schumaker reports.

Health data company H1 added former FDA Commissioner Stephen Hahn to its board of directors, Modern Healthcare’s Gabriel Perna reports.

Two older GLP-1 drugs — diabetes drugs exenatide and liraglutide — now have generic competition, potentially giving Medicare a greater ability to negotiate a lower price for semaglutide, STAT’s John Wilkerson reports.

A message from AMAC Action:

The IRA took money from Medicare Part D to fund EV tax credits under the guise of a fake “drug price negotiation.” As premiums are skyrocketing, seniors are demanding their money back.

70% of seniors are calling on Congress to pause the Inflation Reduction Act.

85% of them want the money that was taken from Medicare to fund EV tax credits to be returned to Medicare where it belongs.

Congress: It’s time to pause the IRA and fix what it broke, first by giving money back to Medicare.

Visit PauseTheIRA.com to learn more.