FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

Noncorrective contact lenses: regulate as medical devices (S. 172), S9547, S9585 [29JY]

Bills and resolutions

Advertising: amend relative to drug advertising (see H.R. 3950), H8642 [29SE]

Consumers: safeguard public health and provide food that is safe, unadulterated, and honestly presented (see H.R. 2235), H3112 [10MY]

Crime: enhance penalties for certain violations involving concealment of evidence of a serious adverse drug experience (see H.R. 870), H719 [16FE]

Dietary supplements: amend relative to dietary supplements (see H.R. 3156), H5600 [30JN]

Drugs: allow for medicinal use of marijuana in accordance with State laws (see H.R. 2087), H2976 [4MY]

———create a three-tiered approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients (see S. 1956), S12353 [3NO]

———establish recall authority for drugs and increase criminal penalties for sale or trade of knowingly adulterated or misbranded prescription drugs (see S. 1978), S12606 [9NO] (see H.R. 2345), H3261 [12MY]

———establish recall authority for drugs and increase criminal penalties for sale or trade of prescription drugs knowingly adulterated or misbranded (see H.R. 1396), H1692 [17MR]

———protect the public from unsafe importation of prescription drugs and from counterfeit prescription drugs (see S. 184), S574 [26JA] (see H.R. 753), H582 [10FE]

FDA: ensure autonomy and eliminate conflicts-of-interest relative to drug company fees and advisory panels, improve postmarket drug safety, regulate off-label uses, and clarify liability for approved drugs (see H.R. 2090), H2976 [4MY]

———improve ability to ensure drug safety (see S. 930), S4398 [27AP] (see H.R. 4429), H11034 [18NO]

———prohibit the approval of any drug that infringes the right to life (see H.R. 3553), H7558 [28JY]

———provide for uniform food safety warning notification requirements (see H.R. 4167), H9361 [27OC]

Food: amend inspection laws to notify consumers of products produced from crops, livestock, or poultry raised on sewage sludge-treated land (see H.R. 207), H78 [4JA]

———include freshness dates on food labeling (see H.R. 3570), H7559 [28JY]

———require foods containing certain ingredients derived from meat, poultry, or other animal products to bear labeling that states that fact and the names of such ingredients (see H.R. 3571), H7559 [28JY]

Hazardous substances: reduce human exposure to mercury through vaccines (see S. 1422), S8487 [19JY] (see H.R. 881), H791 [17FE]

Health: amend relative to medical device user fees (see S. 1420), S8419 [18JY] (see H.R. 3423), H6431 [25JY]

———ensure that health claims for foods and dietary supplements include accurate statements of the curative, mitigation, treatment, and prevention effects of nutrients on disease or health-related conditions (see H.R. 2352), H3261 [12MY]

———require the FDA to disclose benefits of foods and dietary supplements and ensure the FTC bears the burden of proof in false advertising cases involving dietary supplements (see H.R. 4282), H10145 [9NO]

Medicaid: require drug manufacturers to report the average manufacturer price and the best price of authorized generic drugs and any other drugs sold under a certain new drug application to the Dept. of HHS (see S. 1903), S11665 [20OC]

Noncorrective contact lenses: regulate as medical devices (see S. 172), S573 [26JA] (see H.R. 371), H233 [26JA]

Pharmaceuticals: establish requirements to allow sale of prescription drugs over the Internet (see S. 399), S1513 [16FE] (see H.R. 840), H717 [16FE]

———establish therapeutic equivalence requirements for generic drugs (see H.R. 2299), H3198 [11MY]

———impact of illegal importation of prescription drugs on regulatory protections afforded consumers (see H. Con. Res. 75), H796 [17FE]

———importation of prescription drugs (see S. 334), S1198 [9FE] (see H.R. 328), H194 [25JA] (see H.R. 700), H521 [9FE]

———preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (see S. 742), S3358 [7AP] (see H.R. 2562), H3892 [24MY]

———prohibit sale or trade of prescription drugs that were knowingly adulterated or misbranded (see H.R. 2600), H3893 [24MY]

———provide tax credit to retirement age individuals, remove barriers to importation, and prohibit certain regulation of Internet sites relative to prescription drugs (see H.R. 578), H351 [2FE]

———standardize certification of Internet pharmacies and prohibit certain advertising by, and use of certain bank instruments for purchases from, illegal Internet pharmacies (see H.R. 1808), H2471 [21AP]

Letters

Require manufacturers of dietary supplements to submit reports on certain serious adverse events before allowing sale on military installations: Bruce Silverglade and Ilene R. Heller, Center for Science in the Public Interest, S8637 [21JY]

———Debbie Riggins, S8636 [21JY]

———Janell Mayo Duncan, Consumers Union, S8637 [21JY]

———Kevin S. Riggins, S8636 [21JY]

———Michelle Skinlo, S8636 [21JY]

———Philip Shettle, American Osteopathic Association, S8637 [21JY]

Remarks in House

Crime: enhance penalties for certain violations involving concealment of evidence of a serious adverse drug experience (H.R. 870), E252 [16FE]

Dietary supplements: amend relative to dietary supplements (H.R. 3156), E1441 [1JY]

Drugs: establish recall authority for drugs and increase criminal penalties for sale or trade of knowingly adulterated or misbranded prescription drugs (H.R. 2345), E950 [12MY]

FDA: ensure autonomy and eliminate conflicts-of-interest relative to drug company fees and advisory panels, H4245-H4247 [8JN]

———improve postmarket drug safety, H4206, H4219, H4221, H4242, H4244 [8JN]

Health: amend relative to medical device user fees (H.R. 3423), H6510 [26JY], E1633 [27JY], E1687 [29JY]

———ensure that health claims for foods and dietary supplements include accurate statements of the curative, mitigation, treatment, and prevention effects of nutrients on disease or health-related conditions (H.R. 2352), E968 [13MY]

———require the FDA to disclose benefits of foods and dietary supplements and ensure the FTC bears the burden of proof in false advertising cases involving dietary supplements (H.R. 4282), E2313 [9NO]

Noncorrective contact lenses: regulate as medical devices (S. 172), H9196-H9198 [26OC]

Pharmaceuticals: importation of prescription drugs, H418 [9FE], H4220 [8JN], H4861 [21JN], H6654 [27JY]

———importation of prescription drugs (H.R. 328), H1945, H1947 [13AP], H3289 [16MY], H4373 [13JN], H9934 [7NO]

———provide tax credit to retirement age individuals, remove barriers to importation, and prohibit certain regulation of Internet sites relative to prescription drugs (H.R. 578), E144 [2FE]

Remarks in Senate

Dietary supplements: require manufacturers to submit reports on certain serious adverse events before allowing sale on military installations, S8635-S8638 [21JY]

———withhold funding from stores on military installations that sell dietary supplements containing stimulants in cases that the manufacturer does not report associated serious adverse events, S11096-S11099 [5OC]

Drugs: protect the public from unsafe importation of prescription drugs and from counterfeit prescription drugs, S5433 [18MY]

FDA: condemn delay of decision on the approval of over-the-counter emergency contraceptives, S10249 [21SE]

———ensure autonomy and eliminate conflicts-of-interest relative to drug company fees and advisory panels, S10217 [20SE]

———improve ability to ensure drug safety (S. 930), S4426, S4427 [27AP], S13095 [17NO]

———Inspector General investigation funding relative to delay of decision on the approval of over-the-counter emergency contraceptives, S11907 [26OC]

Health: amend relative to medical device user fees (H.R. 3423), S9196 [27JY]

———amend relative to medical device user fees (S. 1420), S8940 [26JY]

Inspector General: investigation funding relative to delay of decision on the approval of over-the-counter emergency contraceptives, S11907 [26OC]

Medicaid: eliminate increase in rebate for generic drugs, S12318, S12319 [3NO]

Noncorrective contact lenses: regulate as medical devices (S. 172), S9585 [29JY]

Pharmaceuticals: establish requirements to allow sale of prescription drugs over the Internet (S. 399), S1531, S1534 [16FE]

———importation of prescription drugs (S. 334), S1206 [9FE], S1253, S1256 [10FE], S10077 [15SE]

———preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (S. 742), S3407 [11AP]

Reports filed

Medical Device User Fee Stabilization Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 1420) (S. Rept. 109-107), S8826 [25JY]

Regulation of Noncorrective Contact Lenses as Medical Devices: Committee on Health, Education, Labor, and Pensions (Senate) (S. 172) (S. Rept. 109-110), S9157 [27JY]

Texts of

H.R. 3423, Medical Device User Fee Stabilization Act, H6510 [26JY]

S. 172, regulate noncorrective contact lenses as medical devices, S580 [26JA], S9585 [29JY], H9196 [26OC]

S. 399, Internet Pharmacy Consumer Protection Act, S1532-S1534 [16FE]

S. 1956, Access, Compassion, Care, and Ethics for Seriously Ill Patients (ACCESS) Act, S12355-S12357 [3NO]