Protecting America's Life Saving Medicines Act of 2019

To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to conduct a study on high-risk, high-reward drugs, and for other purposes. 1. Short title This Act may be cited as the Protecting America’s Life Saving Medicines Act of 2019 2. Study on high-risk, high-reward drugs (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall conduct a study to determine which of the drugs that are being tested (as of such date of enactment) under subsection (i) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 (b) Submission to Treasury Not later than 180 days after the completion of the study under subsection (a), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall transmit to the Secretary of the Treasury (or the Secretary’s delegate) a list of the drugs that the Secretary of Health and Human Services determines meets the criteria specified in subsection (a). 3. Credit for clinical testing expenses for certain high-risk, high-reward drugs (a) In general Subpart D of part IV of subchapter A of chapter 1 45T. Clinical testing expenses for certain high-risk, high-reward drugs (a) In general For purposes of section 38, the credit determined under this section for the taxable year is an amount equal to 25 percent of the qualified clinical testing expenses for the taxable year. (b) Qualified clinical testing expenses For purposes of this section— (1) Qualified clinical testing expenses (A) In general Except as otherwise provided in this paragraph, the term qualified clinical testing expenses (B) Modifications For purposes of subparagraph (A), subsection (b) of section 41 shall be applied— (i) by substituting clinical testing qualified research (ii) by substituting 100 percent 65 percent (C) Exclusion for amounts funded by grants, etc The term qualified clinical testing expenses (2) Clinical testing The term clinical testing (A) which is carried out with respect to a drug on a list submitted to the Secretary under subsection (b) of the Protecting America’s Life Saving Medicines Act of 2019 (B) which occurs— (i) after the date such list is so submitted, and (ii) before the date on which an application with respect to such drug is approved under section 505(b) of such Act or, if the drug is a biological product, before the date on which a license for such drug is issued under section 351 of the Public Health Service Act. (c) Coordination with credit for increasing research expenditures (1) In general Except as provided in paragraph (2), any qualified clinical testing expenses for a taxable year to which an election under this section applies shall not be taken into account for purposes of determining the credit allowable under section 41 for such taxable year. (2) Expenses included in determining base period research expenses Any qualified clinical testing expenses for any taxable year which are qualified research expenses (within the meaning of section 41(b)) shall be taken into account in determining base period research expenses for purposes of applying section 41 to subsequent taxable years. (d) Special rules (1) Certain rules made applicable Rules similar to the rules of paragraphs (1) and (2) of section 41(f) shall apply for purposes of this section. (2) Election This section shall apply to any taxpayer for any taxable year only if such taxpayer elects (at such time and in such manner as the Secretary may by regulations prescribe) to have this section apply for such taxable year. . (b) Credit made part of general business credit Subsection (b) of section 38 plus , plus (33) the credit determined under section 45T. . (c) Clerical amendment The table of sections for subpart D of part IV of subchapter A of chapter 1 of such Code is amended by adding at the end the following new item: Sec. 45T. Clinical testing expenses for certain high-risk, high-reward drugs. (d) Effective date The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.

Summary: Protecting America's Life Saving Medicines Act of 2019 This bill directs the Food and Drug Administration (FDA) to conduct a study on drugs that are currently being tested and are unlikely to be approved, but would, if approved, address an unmet medical need for the treatment of a serious or life threatening disease or condition or a rare disease or condition (high-risk, high-reward drugs). The FDA must submit to the Department of the Treasury a list of such high-risk, high-reward drugs not later than 180 days after the completion of the study. The bill also allows a new tax credit for 25% of the clinical testing expenses for high-risk, high-reward drugs.