Policy Roundup
Rachel Balick
Though both Republicans and Democrats have named high drug prices as policy priorities, hyperpartisanship in what’s sure to be a brutal election year could mean continued gridlock: Both parties are loath to give their opponents successes to tout on the campaign trail. While congressional possibilities remain ambiguous, other legal and regulatory issues facing pharmacists and their patients march on. Here’s the latest at press time.
Trump administration pushes drug importation
On December 17, 2019, the Trump administration released a proposal that, if finalized, would allow states, wholesalers, and pharmacies to creep toward importing drugs from foreign nations. A second proposed policy would allow manufacturers to import their own products sold abroad. The policies must survive multiple regulatory hurdles—which could take months or years—before they can be implemented.
Pharmacy organizations and advocates have long asserted that importation poses an unacceptable threat to public safety. Other importation skeptics question whether the process of shipping drugs in proper conditions, ensuring drugs are genuine and have not been adulterated or tampered with, and physically relabeling each bottle so labels conform to U.S. regulations and standards and redistributing them would result in net savings.
Other criticisms raise concerns about whether Canada’s drug supply, subject to the same shortages that occur in the United States and serving significantly fewer residents, could meet the needs of a population of a nation nearly 10 times its size. Furthermore, the policy wouldn’t apply to insulin and biologics.
Still, safety is the most persistent and intractable concern. In a statement released on Wednesday, December 18, APhA said “[The] safeguards to protect Americans … to ensure that prescription drugs are manufactured, stored, shipped, and dispensed in a safe manner would be undermined if this proposal is finalized as written. This would have a negative effect on patient confidence in the safety of their medications.”
FDA’s proposed rule creates a patchwork of interim supply chain measures that introduce gaps and loopholes in the supply chain, even as U.S. pharmacists and other drug supply chain stakeholders have worked for years to implement the Drug Supply Chain Security Act (DSCSA). Also known as track-and-trace, DSCSA creates a closed supply chain to “track-and-trace” prescription drugs as they move from manufacturer to distributor to pharmacist. Canada has no such safeguards.
Though U.S. Department of Health and Human Services’s Secretary Alex Azar in May 2018 referred to importation as a “gimmick,” adding that “the last four FDA commissioners have said there is no effective way to ensure drugs coming from Canada really are coming from Canada, rather than being routed from, say, a counterfeit factory in China,” his tone has softened.
“We will move as quickly as humanly possible here,” Azar stated on December 17, 2019. “President Trump is fervently committed to bringing down drug prices, fervently committed to the importation of safe drugs from Canada.”
APhA remains alarmed by the idea. “[The FDA] proposal undermines the DSCSA’s protections by introducing unsecure foreign prescription drug packages into our drug supply and commingling them with secure FDA-approved products,” APhA said. “The lack of clarity around unknown, unproven cost savings does not justify jeopardizing U.S. supply chain integrity and patient safety.”
Only one drug pricing policy passed in 2019
Despite the prominence of the issues for both Republicans and Democrats, only one drug pricing policy will cross the finish line in 2019. The CREATES Act (S. 340/H.R. 965) was enacted as part of federal appropriations bills Congress must pass each year to avoid a government shutdown.
The legislation is aimed at bringing generics and biosimilars to market more quickly. Under the law, drug manufacturers are prohibited from refusing to sell samples of their products to other manufacturers who want to develop generic alternatives. Generic drugmakers can sue if the makers of the reference product decline to provide samples. It also relaxes impediments that make it difficult to bring to market generic versions of drugs that are subjected to REMS, FDA-mandated safety programs.
PhRMA opposed the legislation, which is expected to save the government about $3.8 billion over the decade.
Reps. Lauren Underwood (D-IL) and Brett Guthrie (R-OH), two of the sponsors of the Lower Insulin Costs Now Act, also claimed the enacted legislation’s language as a victory for their bill. The language allows generic insulins undergoing the FDA approval process to hit the market a year earlier than they otherwise would have become available.
APhA signs on to letter targeting PBM spread pricing
On December 11, APhA joined other pharmacy and grocery organizations in a joint letter urging Reps. Kurt Shrader (D-OR) and Greg Gianforte (R-MT) to fix their legislation attempting to address the abusive practice of spread pricing by PBMs. Spread pricing occurs when health plans contract with PBMs to manage their prescription drug benefits, and PBMs keep a portion of the amount paid to them by the health plans for prescription drugs instead of passing the full payments on to pharmacies.
The organizations that signed the letter could not support the bill because of two major loopholes or exceptions that would allow PBMs to continue to engage in spread pricing. First, the bill excludes “penalties paid by pharmacies to such plan, issuer, or entity,” which allows PBMs to circumvent the spirit of the legislation by giving them the ability to make up any lost “spread” through fees, penalties, or clawbacks (such as DIR fees) imposed on pharmacies for almost any reason. Second, the legislation would still allow employers or plans to choose to allow spread pricing in contracts. These organizations have offered to help Reps. Shrader and Gianforte fix this legislation and others to increase PBM transparency and lower the cost of prescription drugs.
CMS safety alerts at point of opioid dispensing continues
Since January 1, 2019, CMS announced new strategies to help prevent and combat opioid overuse, including additional safety alerts at the time of dispensing to better engage patients, prescribers, and pharmacists. To help pharmacists in 2020, APhA has developed two resources: Medicare Opioid Care Coordination Soft Edit in 2019 and 2020 and Medicare Part D Opioid Safety Edits in 2019 and 2020 (https://apha.us/2020edits). APhA also wants to ensure members are aware that opioid-naive edits should not affect patients who already take opioids but may occur for patients who enroll in a new plan that does include their current prescription information. See the figure for tips on how to communicate with prescribers.