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PROLOGUEPharmaceuticals & Psychotropic DrugsThe invention of new pharmaceutical products has resulted in tremendous benefits for patients with mental health conditions. Antidepressants, for example, have relieved symptoms for millions for whom treatment was previously unavailable or ineffective. But greater reliance on pharmaceutical treatments has increased the vulnerability of those with mental illnesses to changes in the policies of public or private payers. Increased spending has prompted insurers, regulators, and public programs to experiment with coverage policies, formularies, patent law, and payment strategies—and sometimes has led pharmaceutical manufacturers to take actions that are not always in the public’s interest. Patients’ well-being is at stake at every turn. The papers in the following section examine some of these policy changes. They highlight potential risks to patients, but also the nuance and complexity of the decisions facing policymakers and the absence of easy choices. In all cases, they point to the need for careful monitoring and objective assessment of the effects of pharmaceutical policies in mental health as patient outcomes become apparent. Susan Busch and Colleen Barry, both of Yale University, trace the causes and consequences of the Food and Drug Administration’s decision to order a "black-box" warning on pediatric antidepressant use after studies found increased risk of suicidality. A sharp drop in prescriptions of these drugs, however, has had problematic implications. Harvard’s Haiden Huskamp and colleagues examine the controversial subject of patent extensions for reformulated versions of existing drugs. They find mixed evidence on the therapeutic value of reformulations, suggesting that refinement of patent policy will be resistant to simple solutions. Finally, Julie Donohue of the University of Pittsburgh, with Huskamp and Samuel Zuvekas of the Agency for Healthcare Research and Quality, assess the effects of shifting responsibility for drug payments from Medicaid to Medicare for beneficiaries eligible for both programs. The risks they find to patient access and continuity of treatment warrant careful monitoring.
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