FEDERAL FOOD, DRUG, AND COSMETIC ACT

Bills and resolutions

Agriculture: authorize the interstate traffic of unpasteurized milk and milk products in final package form for human consumption between States that allow the sale of such products (see H.R. 4307), H2695 [26MR]

——— prohibit Federal interference in interstate traffic of unpasteurized milk and milk products in final package form for human consumption between States that allow the sale of such products (see H.R. 4308), H2695 [26MR]

Chemicals: allow marketing, distribution, or sale of solid antimicrobial copper alloys with certain claims and exclude certain solid antimicrobial copper alloys from regulation as drugs or devices (see H.R. 5350), H7182 [31JY]

Dept. of HHS: prevent abuse of dextromethorphan by restricting over-the-counter sales and bulk distribution (see H.R. 3969), H1510 [29JA]

——— require NIH to consider sex differences in medical research and direct FDA to guarantee clinical drug trials are sufficient to determine safety and effectiveness for both men and women (see H.R. 4879), H5398 [17JN]

Diseases: continue progress toward the goal of eliminating tuberculosis (see H.R. 5835), H9044 [10DE]

Drugs: improve DEA scheduling process for new FDA-approved drugs under the Controlled Substances Act and registration process for use of controlled substances in clinical trials (see S. 2862), S5782 [18SE] (see H.R. 4299), H2694 [26MR]

——— provide for legitimate use of medicinal marijuana in accordance with State laws (see H.R. 4498), H3240 [28AP]

FDA: create a limited population pathway for approval of certain antibacterial drugs (see S. 2996), S6540 [10DE]

——— ensure eligible product developers have competitive access to approved drugs and licensed biological products to enable development and testing of new products (see H.R. 5657), H7886 [18SE]

——— ensure that liquid over-the-counter medications are packaged with appropriate dosage delivery devices and, in the case of such medications labeled for pediatric use, appropriate flow restrictors (see H.R. 5613), H7885 [18SE]

——— establish Federal labeling standards for food with genetically modified ingredients and natural foods (see H.R. 4432), H3142 [9AP]

——— establish recall authority for drugs and increase criminal penalties for sale or trade of knowingly adulterated or misbranded prescription drugs (see H.R. 5874), H9303 [11DE]

——— expand priority review voucher incentive program to encourage treatments for tropical diseases (see H.R. 5729), H8071 [18NO]

——— extend market exclusivity periods for drugs approved to prevent, diagnose, or treat a rare disease or condition (see H.R. 5750), H8169 [20NO]

——— provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients (see S. 2141), S1652 [13MR] (see H.R. 4250), H2433 [13MR]

——— provide for the regulation of patient records and certain decision support medical software (see S. 2977), S6350 [4DE]

——— reform program allowing for expanded access to certain experimental treatments or breakthrough drugs for seriously ill patients (see H.R. 5805), H8867 [8DE]

——— require bottled water manufacturers and distributors to disclose bottled water quality information (see H.R. 4978), H5816 [26JN]

Health: provide regulatory clarity over clinical and health software and relieve categories of such low-risk software from the medical device tax (see S. 2007), S852 [10FE]

Pharmaceuticals: allow importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients (see H.R. 5854), H9302 [11DE]

——— allow manufacture, importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients (see H.R. 4475), H3196 [10AP]

——— allow personal importation of safe and affordable drugs from approved pharmacies in Canada (see S. 2549), S4153 [26JN]

Product safety: ban use of bisphenol A in food and beverage containers (see S. 2572), S4336 [9JY] (see H.R. 5033), H6034 [9JY]

Letters

Sunscreen Innovation Act: Brett M. Coldiron, American Academy of Dermatology Association, H6931 [28JY]

——— Christopher W. Hansen, American Cancer Society, H6931 [28JY]

——— Mary Antonucci, Melanoma Research Foundation, H6932 [28JY]

——— Steven Goldberg, BASF Corp., H6931 [28JY]

——— Wendy K.D. Selig, Melanoma Research Alliance, H6932 [28JY]

Remarks in House

Drugs: reschedule marijuana under the Controlled Substances Act and allow for medicinal use of marijuana in accordance with State laws, H2995 [8AP], H4053–H4055 [9MY]

FDA: extend market exclusivity periods for drugs approved to prevent, diagnose, or treat a rare disease or condition (H.R. 5750), H8938 [10DE]

——— improve priority review voucher incentive program for expedited review of treatments for tropical and rare pediatric diseases, E1321 [1AU]

——— provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients (H.R. 4250), H6928–H6933 [28JY], E1304 [1AU]

——— provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients (S. 2141), H7959 [13NO]

Food industry: improve and clarify certain disclosure requirements for restaurants, similar retail food establishments, and vending machines (H.R. 1249), E966 [12JN]

Remarks in Senate

FDA: provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients (S. 2141), S1725 [25MR], S5715–S5720 [17SE]

Health: provide regulatory clarity over clinical and health software and relieve categories of such low-risk software from the medical device tax, S1557 [12MR]

——— provide regulatory clarity over clinical and health software and relieve categories of such low-risk software from the medical device tax (S. 2007), S853, S854 [10FE]

Reports filed

Improving Regulatory Transparency for New Medical Therapies Act: Committee on Energy and Commerce (House) (H.R. 4299) (H. Rept. 113–565), H7038 [29JY]

——— Committee on the Judiciary (House) (H.R. 4299) (H. Rept. 113–565), H7900 [19SE]

Sunscreen Innovation Act: Committee on Energy and Commerce (House) (H.R. 4250) (H. Rept. 113–558), H6813 [24JY]

——— Committee on Health, Education, Labor, and Pensions (Senate) (S. 2141), S5697 [17SE]

Texts of

H.R. 4250, Sunscreen Innovation Act, H6928–H6930 [28JY]

S. 2141, Sunscreen Innovation Act, S5715–S5720 [17SE], H7959–H7964 [13NO]