and more about the discretion that the agency continuously exercised about what is and what is not cci. court decisions through the 1980s and beyond constrained that discretion, but so too has the agency gained a statutory mandate from congress to disclose safety alerts, warning lerts letters, as well as, quote, other materials deemed relevant by the fda to the question of drug safety. implementing the blueprints recommendations would serve as a critically important reminder of the discretion that the fda continues to enjoy about what information it can and cannot share and to correct the problem which is to some extent a problem of its own making. the second institutional reason to improve the transparency of fda's decisions and data concerns regulatory harmonization. for years, regulators have espoused this goal. apart from the pilot that we heard about this morning, insofar as the fda continues to withhold negative decisions and nonsummary level data, including csrs, and individual patient-level data from public purview, the u.s. regulator is apt to be out of step with other jurisdi