Drug recalls represent an ongoing safety problem for patients and doctors, and an ongoing cost problem for those paying for drugs, meaning patients (who usually only pay for a small portion of drug costs in the form of copays or coinsurance) and their employers or the federal and state governments (which usually pay for the rest of drug costs). When recalls occur, patients can sometimes be reimbursed for unused pills, if patients return unused units. However, manufacturers rarely agree to reimburse the entities paying for most of the drugs’ costs, a situation that the marketplace needs to alter.
Drug recalls are not infrequent, as is evidenced by the treasure trove of information collected by the outstanding Pharmalot blog about 11 Johnson & Johnson recalls (including for products such as Tylenol, Mylanta, Motrin, Rolaids and Benadryl). Drug recalls of prescription drugs are also continuously occurring, including most recently for costly commonly used drugs like Pfizer’s Lipitor and even extremely expensive biologics.
Accordingly, when payers draft and negotiate drug coverage contracts with PBMs, payers should include provisions that require the PBMs to provide whatever information may be necessary to enable the payers to obtain refunds from manufacturers for drug recalls. When the next very-costly recall occurs, you should not find yourself without the ability to be reimbursed for large sums of money.