AKAO 2017 Annual Report

71 The FDA closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling and regulatory requirements. The FDA also imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we do not restrict the marketing of our products only to their approved indications, we may be subject to enforcement action for off-label marketing. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with regulatory requirements of the FDA and/or other non-U.S. regulatory authorities, we could be subject to administrative or judicially imposed sanctions, including: • warning letters or untitled letters; • mandated modifications to promotional materials or the required provision of corrective information to healthcare practitioners; • restrictions imposed on the product or its manufacturers or manufacturing processes; • restrictions imposed on the labeling or marketing of the product; • restrictions imposed on product distribution or use; • requirements for post-marketing clinical trials; • suspension of any ongoing clinical trials; • suspension of or withdrawal of regulatory approval; • voluntary or mandatory product recalls and publicity requirements; • refusal to approve pending applications for marketing approval of new products or supplements to approved applications filed by us; • restrictions on operations, including costly new manufacturing requirements; • seizure or detention of our products; • refusal to permit the import or export of our products; • required entry into a consent decree, which can include imposition of various fines (including restitution or disgorgement of profits or revenue), reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance; • civil or criminal penalties; or • injunctions. Widely publicized events concerning the safety risk of certain drug products have resulted in the withdrawal of drug products, revisions to drug labeling that further limit use of the drug products and the imposition by the FDA of risk evaluation and mitigation strategies (“REMS”) to ensure that the benefits of the drug outweigh its risks. In addition, because of the serious public health risks of high profile adverse safety events with certain products, the FDA may require, as a condition of approval, costly REMS programs. The regulatory requirements and policies may change and additional government regulations may be enacted for which we may also be required to comply. For example, in December 2016, the 21st Century Cures Act, or Cures Act, was signed into law. The Cures Act, among other things, is intended to modernize the regulation of drugs and spur innovation, but its ultimate implementation is unclear. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or any future collaboration partner are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.