Risks 1. Discovery a. Extend data exclusivity period for areas of unmet need. b. Extend exclusivity period for small-molecule therapies. c. Sync the data exclusivity period for drugs approved under section 505(b) of the FDCA and biologicals approved under section 351 of the PHSA. d. Provide market exclusivity – independent of patent life – for compounds that attenuate Alzheimer’s pathology and slow dementia progression. 2. Discovery/Development e. "HR 3116: The Moddern Cures Act i. Extends exclusivity period for diagnostic tests developed by or with the manufacturer or sponsor of the medicine, and used to identify patient populations for the medicine. ii. Establishes dormant therapy designation for medicine that addresses unmet needs, 15 years of data exclusivity. iii. Directs IOM study on intellectual property laws." 3. Clinical Trials f. Establishment of a Rare Disease Ombudsman within HHS. iv. Provide recommendations to the Secretary regarding guidelines on appeals and grievance processes and protections that ensure patients with rare disorders receive access to high quality treatment. v. Review and advise the Secretary regarding design features critical to patients with rare disorders and unmet medical needs, including, but not limited to, access to prescription drugs, out of pocket costs, and network adequacy. vi. Serve as a single point of contact for patients with rare diseases to address unique issues that impact access to care. vii. Play a role in ensuring that rare disease patients are accessing the necessary care through insurance plans offered under the state marketplaces. g. "Enable the FDA to use “real-world evidence” for certain products as a supplement or potentially as a replacement for randomized controlled trials, as