Financial Assistance from a Pharma Company

Darshan: So let's ask a question. Is it legal for a pharmaceutical company to provide financial assistance for travel, lodging and other expenses to certain patients prescribed the manufacturer's drug? Narrator: This is the Darshan Talks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website @darshantalks.com. Darshan: This was an OIG opinion from January 2020. And I thought it would make sense to explore exactly what the OIG gave an opinion on, what the implications are, and why it matters. Darshan: So the drug in question is a personalized medicine made from the patient's own cells in a one time potentially curative treatment. The drug is approved for one of two indications, it's either refractory or recurrent. Generally affects children or young adults, or it's affecting adults. So what is the drug itself? It's a drug that has what's called a REMS on it and only REMS certified physicians can ... treat the disease using the drug. Darshan: The physicians who are allowed to do this, they accept the responsibility for implementing the necessary safety protocols and may prescribe and administer the drugs. Consistent with the REMS, the requestors enter into arrangements with certain inpatient/outpatient facilities, which we're calling the centers, to infuse the drug. Darshan: These facilities also additionally perform leukapheresis and collect, process, package, and ship the patient's white blood cells to the requestor, so that requestor may use the patient's cells. The requestor being the pharmaceutical company in this specific instance, I expect ... May use the patient's cells to individually manufacturer the drug. Darshan: So what does the center need to be able to do? The facility, the center must meet applicable regulatory requirements for third party cell collection, processing and other requirements, including having onsite immediate access to the drug itself, which is used to treat severe instances of therapy related syndrome. Darshan: Essentially they need to be able to manage results that can come out ... the adverse events of this drug and of disease itself. They must ensure that physicians who prescribe, dispense or otherwise administer the drug, are trained in the management of the syndrome and potential neurological toxicities. Darshan: And the pharmaceutical manufacturer in this specific instance certifies that it does not require either the physicians or the centers to prescribe the drug exclusively. And that any facility that meets all the REMS with the ETASU requirements and the requestor's criteria may become a center. So the key piece here is, why is the proximity necessary? Darshan: The proximity of the center is necessary because, A, number one to handle the fact that these patients may be required to stay there for a little bit, and only certain facilities can handle it and handle the training that's required. Under the arrangement, the pharmaceutical company proposes treating eligible Disease A patients, being the older patients, and disease B patients as well. Darshan: And depending on whether you have Disease A or Disease B, they give up to two caregivers for lodging, travel, meals and certain out of pocket expenses. So if you're a child, you'd get two caregivers. I expect it might be the parents ... up to two caregivers. Darshan: For Disease B, patients who are 26 and older, they provide the same level of support for a patient and one caregiver. The requestor does not provide assistance with patient travel or expenses associated with the initial patient consultations with the leukapheresis, or following up visits beyond the post infusion monitoring required by the drugs prescrib...