A pharmacy rule pending in Oklahoma could be the first in the nation to tighten safety on temperature exposure for mailed medications, but it faces powerful opposition.
A proposed state regulation in Oklahoma that could have major implications for millions of Americans who get prescription drugs by mail is facing fierce opposition from some powerful industry groups.
Representatives from CVS Health, the nation’s biggest health care company, and a trade group of companies that run prescription drug plans descended on a meeting of the state pharmacy board in Oklahoma City last week to oppose approval of the nation’s first detailed rule aimed at protecting prescription medication from extreme temperatures during shipping to patients. Still more companies, national health care organizations, state business associations and a postal worker’s union submitted written opposition to the rule — including one pharmacy company that had served on the committee that drafted it.
“In the four and a half, five years I’ve been with the board, we’ve never encountered this much in public comment,” the executive director of the state pharmacy board, Marty Hendrick, told NBC News after the meeting.
The board approved the rule in a unanimous 4-0 vote, but the unusual lobbying presence at its meeting suggests a more difficult fight to come as the rule heads to Oklahoma’s business-friendly Republican Legislature and governor for final approval.
With Texas regulators discussing strengthening their rules on temperature control in shipping at a pharmacy board meeting on Tuesday, such fights could soon be playing out across the country.
The proposed Oklahoma rule is the first to set clear guidelines on temperature safety during the transit of drugs from pharmacies to patients. It would require all pharmacies shipping or delivering medication to use packaging tested to ensure that drugs do not go outside their safe temperature ranges, which can potentially degrade their effectiveness. It would also require that providers be able to assess the safety of a medication if delivery is delayed, and mandate that patients receive notification of shipping and delivery.
It comes after an NBC News investigation in 2020 found that oversight of shipping from pharmacies to patients is largely a system of blind trust, and that during shipping some drugs may be exposed to potential damage from heat waves and freezing temperatures. At the time, most state pharmacy boards, the regulators responsible for the safety of drugs handled by pharmacies, did not have specific rules for how pharmacies should ship customers’ medication, few asked about this process in their inspections, and many said it was simply up to the pharmacy to ensure safe shipping. Mail-order pharmacy has become a booming business, with soaring profits for some of the nation’s largest companies in recent years and over 26 million people receiving their medication by mail in 2017 — more than double the number two decades earlier, according to federal data.
The delivery boom and the increasing frequency of extreme temperatures like last week’s national cold front have increased concerns about temperature safety by regulators like the Oklahoma and Texas boards and prompted studies by pharmacy schools.
Hendricks of the Oklahoma board noted that many companies already take temperature into account when shipping medication to patients, especially refrigerated medication, often using packaging specifically designed to control for weather for a set amount of time, or inexpensive devices that can track if the package reaches an unsafe temperature. The new rule would clarify that such safety methods should be used for all medications shipped into or within the state.
“If everyone is doing it correctly, then there really won’t be anything to change anybody’s shipping patterns,” said Hendricks. “These rules will be in place just as a safety and guidance.”
But opposition to the rule took many forms, many focused on cost and whether it was fair for companies that ship drugs to patients to face safety regulations that are not applied to other parts of the supply chain.
Lobbyist Audrey Renegar spoke on behalf of the Pharmaceutical Care Management Association, which represents pharmacy benefit managers (PBMs) — the companies that administer prescription drug plans for more than 275 million Americans and often operate their own mail-order pharmacies. She described the language of the rule as “not grounded in science and evidence, rather [it] appears to be based on speculation and an attempt to resolve a perceived issue.”
Renegar argued that the board had not sufficiently considered economic impact and asked it to withdraw the rule, saying it would be ineffective unless applied to the entire pharmaceutical supply chain, which falls under multiple regulators. Greg Lopes, a spokesperson for the trade group, reiterated Renegar, telling NBC News that the “proposed rule is based on a flawed economic impact analysis, fails to consider the multi-faceted nature of the pharmaceutical supply chain, and will only increase costs on Oklahomans." Several board and task force committee members who spoke expressed frustration about the opposition of PBMs. Jay Kinnard, a pharmacist on the temperature task force who works for the Oklahoma University health system, noted the effort that the board had put into getting large pharmacies and pharmacy benefit managers to help draft the rule.
“We had a representative from a PBM there, who was along every step of the way and said, ‘Yeah, I’m for this.’ And then that same company came back and said, ‘Everything you did was wrong,’” he said.
That company was Express Scripts, a pharmacy benefit manager and large mail-order pharmacy. Its senior director of pharmacy regulatory affairs, Richard Palombo, was the only PBM representative on the task force that wrote the rules.
Palombo, along with a representative from Walgreens — another large pharmacy company, but not a pharmacy benefit manager — negotiated the language of the proposed rule and expressed satisfaction with the final version, according to two people who were present for task force meetings. While Express Scripts was not at last week’s board meeting, it provided the longest written public comment, which took a much different tone.
In that comment, the company offered several amendments to the proposed rule and argued that the temperature standards cited in the rule were intended for storage, not shipping. It also urged the board to instead require pharmacies to follow existing accreditation standards that Express Scripts already does, and asked the board to “be mindful that standards it sets may be subject to legal challenges” if they are vague or impose “undue burdens” on pharmacies delivering across state lines.
Express Scripts, a member of the trade group PCMA, did not respond to a request for comment.
Walgreens, the other large health care company on the task force, did not submit public comment on the rule.
CVS Health, a PCMA member, argued in writing that the board’s rule “attempts to solve a perceived issue that is not grounded in any scientific evidence or data.”
The company touted its decades of safe shipping and unique packaging systems for over 400 drugs, while estimating that following the rule would cost the corporation an estimated $550,000-$750,000 a month in additional costs of labor, freight, supplies and reshipping of prescriptions.
Like PCMA’s Renegar, Lauren Paul, executive director of pharmacy regulatory affairs at CVS Health, told the board that if standards for temperature safety in shipping change for pharmacies, they should also change for the other parts of the supply chain, giving an example of a pharmacy that receives hot medication from a wholesaler.
“If you’re requiring the pharmacy to ship in this way, and you [the pharmacy] receive those medications, and they feel warm, the pharmacist can refuse them,” she said. “But at what point does that hinder patient access by not having medications in the pharmacy?”
Hendricks, the board director, pushed back. “So we would hinder access to a medication that could possibly be not good with that [requirement] — wouldn’t that be a good thing?” Another board member interjected to point out that temperature control in shipping for manufacturers and wholesalers falls under federal regulation and is outside the board’s control.
The Oklahoma Legislature is expected to vote on the rule in the next several months.
Reporter: Adiel Kaplan
Adiel Kaplan is a reporter with the NBC News Investigative Unit.