As a new research paper spurs debate, the countdown is ticking on a pandemic-era policy change that may affect one of healthcare marketing’s most controversial tactics. 

Pharma companies give away billions of dollars worth of free prescription drug samples every year. One study found that, based on the retail value of said products, drug sampling as a marketing channel far eclipses the amounts invested in all others combined.

And it’s a highly effective tactic, says Adriane Fugh-Berman, a professor in the Department of Pharmacology and Physiology at Georgetown University Medical Center.

Drugmakers “would not invest so much in optimizing sampling distribution if they did not see a return on investment from these strategies,” she wrote in a new paper arguing to restrict the practice.

The medical and marketing literature, Fugh-Berman noted, suggests that sampling of branded drugs adds to costs, doesn’t necessarily promote access or adherence, and may even “habituate” doctors to prescribing specific products.

But in spite of all that, new regulations have made it easier for pharma companies to distribute samples. The Food and Drug Administration, as per guidance issued in June 2020, relaxed previous restrictions in response to the COVID-19 pandemic. 

Acknowledging that many practitioners weren’t meeting face-to-face with patients or with drug reps, the agency said that samples may be legally dispensed directly from a manufacturer to a consumer’s home. Meanwhile, in another nod to stay-at-home orders and social distancing,  a physical signature is no longer needed for delivery.

Needless to say, the loosening of those rules doesn’t sit well with Fugh-Berman. “Evidence supports a ban on sample distribution of branded products,” she wrote.

The medical establishment doesn’t necessarily agree. Dispensing of drug samples is still considered acceptable by the American Medical Association and the American Academy of Family Practitioners, Fugh-Berman pointed out, and studies have shown that most doctors still accept them. Indeed, academic medicine and the pharma industry have long held their own — and typically opposing — views on the topic of branded medication sampling. 

In his book Pharmaphobia, which details how rules against pharma marketing and industry-sponsored research undermine innovation, the late Harvard hematologist and researcher Tom Stossel cited product sample bans as an example of “flawed and damaging” policy. He wrote that there’s a lack of evidence that restricting samples is associated with improved medical innovation or patient care.

Nevertheless, critics cite the impact on the health system. Most companies distribute free drug samples when they are promoting a branded product, and numerous studies have demonstrated that samples increase prescribing of those drugs.

“It’s widely recognized that free samples should be classified as marketing,” said Aaron Kesselheim, a professor of medicine at Harvard. “Samples can help support use of an expensive drug when a lower-cost option might be just as appropriate for the patient.” 

Joseph Ross, professor of medicine and public health at Yale, explained how this phenomenon occurs.

“When a patient receives a free sample of a branded drug, as opposed to a generic that may be equally effective, and ‘it works,’ both the patient and physician are less likely to change the patient’s prescription when the drug samples run out,” he said. “This leads to more patients being prescribed more expensive drugs when less expensive generic products would work equally well.”

As for why doctors like samples, some believe that they reduce costs for patients. However, other research suggests that samples are less likely to go to poor and uninsured patients.

“Certainly, the issue of high drug prices is an important problem that needs to be addressed and we should be sensitive to patients and their need to afford high-cost drugs,” Kesselheim said. “But samples are not the way to tackle those complicated issues.”

Still other clinicians find them to be a low-risk way of finding the best patient/drug match. That’s not the same as aiding in diagnosis — which, Fugh-Berman pointed out, is not supported by the literature. But once a diagnosis has been made, samples are most often employed to figure out what the right treatment is for patients. 

“Of course samples are a marketing tool,” said Dale Cooke, an industry attorney and owner of PhillyCooke Consulting. To the extent that sampling gives physicians an important tool to determine whether a drug is right for an individual patient, he added, “Marketing is not inherently bad or evil.” Of course, it’s not uncommon for a clinician to have to cycle through multiple prospective treatments to find the right therapy for an individual.

Moreover, as many academic institutions have enacted restrictions on industry interaction, barring reps from their facilities and putting the kibosh on manufacturers stocking the sample closet, the importance of this practice to pharma companies has likely increased.

“Sampling remains one of the most important marketing tools because physicians, who otherwise would not see sales reps, will permit them to come into their facility solely for the purpose of delivering samples,” Cooke explained. “And that’s an incredibly important access point for pharmaceutical companies. Whether that’s a good thing or a bad thing, I leave to the reader to decide.”

Indeed, providing samples is “closely intertwined” with rep visits, Fugh-Berman noted. According to her paper, the use of sample drops as “physician-access enablers,” without which many detailing encounters with physicians may not occur, is well-established in the marketing literature. 

Because of these dynamics, Kesselheim agrees that samples are problematic. Asked whether the potential drawbacks are sufficient to support a ban on use, he responded, “I don’t think samples serve a useful public health purpose, and I think they can promote use of expensive drugs when equally effective lower-cost options are available.”

There may be unique scenarios when free drug samples make more sense for patients, Ross added, particularly when there are no generics available. However, given that sample distribution is most often employed in situations when branded drugs are being marketed against equally effective generics, those cases could be few and far between.

The opposing viewpoints over sampling might have continued on their parallel yet disparate tracks. But an outstanding question remains: Should the FDA’s temporary loosening of the rules that allow samples to be shipped to patient’s homes and received without a doctor’s signature at the shipping address should become permanent?

Those who found sampling irksome to begin with aren’t likely to be thrilled by any substantive erosion of control around the practice. Yet the FDA has said that, following termination of the COVID-19 public health emergency, the agency plans to address the issue. 

“With a lot of these policies, they’re saying, ‘We’re not assuming that the way we did things before the pandemic was obviously the correct way. And we’re absolutely on each one of these policies thinking through to what extent we should maintain the pandemic stance,’” Cooke noted.

In the meantime, without additional guidance at the national level, individual physicians are largely in charge of deciding whether or not to order samples. That uneasy status quo gives Fugh-Berman pause: “This new FDA guidance makes it easier for pharmaceutical companies to distribute samples in spite of decades of evidence that samples cause harm.”

Fugh-Berman wants to see countries, states and other jurisdictions consistently include samples in laws and regulations that address gifts to physicians.

So it’s worth keeping an eye on comments to the FDA draft sampling guidance. Just as it was thoughtful about its initial policies toward pre-pandemic activities, the agency is likely to be just as pragmatic when it comes to the continuation — or rescinding — of policies that were adopted in 2020. 

If the FDA decides to maintain a less-strict stance toward sampling, it’s likely to make those who oppose this controversial practice all the more uncomfortable. Some pharma marketers might even raise an eyebrow. With pandemic-era protocols fading fast, we may be heading toward a resolution sooner rather than later.