hardship to the parties

In 1962 Congress amended the Federal Food, Drug, and Cosmetic Act to require manufacturers of prescription drugs to print the established name of the drug prominently and in type at least half as large as that used for any proprietary name on labels and other printed material. The underlying purpose was to inform doctors and patients that many drugs sold under trade names are identical to those sold under established names at lower prices. The Commissioner of Food and Drugs published proposed regulations in the Federal Register after receiving delegated authority, invited and considered comments from interested parties, and promulgated a regulation requiring that the established name accompany each appearance of the proprietary name on labels and in advertisements for prescription drugs, with a similar rule for advertisements. Thirty-seven individual drug manufacturers and the Pharmaceutical Manufacturers Association, whose members manufacture more than ninety percent of the nation's prescription drugs, brought suit in district court challenging the regulations on the ground that the Commissioner exceeded his statutory authority by imposing an every-time requirement. The District Court granted declaratory and injunctive relief on cross-motions for summary judgment, but the Court of Appeals for the Third Circuit reversed without reaching the merits, holding that pre-enforcement review was unauthorized and that no actual case or controversy existed. The Supreme Court granted certiorari because of the general importance of the question and an apparent conflict with a decision of the Second Circuit. The regulations were promulgated after formal notice-and-comment procedures, were made effective upon publication in the Federal Register, and carried an agency expectation of immediate compliance. Petitioners alleged that compliance would require extensive and costly changes to all labels, advertisements, and promotional materials while noncompliance would expose them to serious criminal and civil penalties.

Susan B. Anthony List is a pro-life advocacy organization. During the 2010 election cycle, SBA publicly criticized Members of Congress who voted for the Patient Protection and Affordable Care Act, including then-Congressman Steve Driehaus. SBA issued a press release announcing its plan to educate voters that their representative voted for a health care bill that includes taxpayer-funded abortion. SBA also sought to display a billboard in Driehaus's district reading "Shame on Steve Driehaus! Driehaus voted FOR taxpayer-funded abortion." The advertising company refused to display the message after Driehaus's counsel threatened legal action. On October 4, 2010, Driehaus filed a complaint with the Ohio Elections Commission alleging that SBA violated the state's false statement statute by making false statements concerning his voting record. A Commission panel held an expedited hearing. On October 14, 2010, the panel voted 2 to 1 to find probable cause that a violation had been committed. The parties then began discovery. On October 18, 2010, SBA filed suit in federal district court seeking declaratory and injunctive relief on First Amendment grounds. The district court stayed the action under Younger v. Harris pending completion of the Commission proceedings. After Driehaus lost his re-election bid in November 2010, he moved to withdraw his complaint. The Commission granted the motion with SBA's consent. SBA then amended its complaint to allege that it intends to engage in substantially similar activity in the future and faces the prospect of its speech being chilled again. The district court consolidated SBA's suit with a separate suit by the Coalition Opposed to Additional Spending and Taxes. COAST alleged that it had refrained from disseminating materials criticizing Driehaus's vote for the ACA due to the proceedings against SBA and desires to make similar statements about other candidates but has been deterred. The district court dismissed both suits as nonjusticiable for lack of sufficiently concrete injury for standing or ripeness. The Sixth Circuit affirmed on ripeness grounds. The Supreme Court granted certiorari.

Following the 1978 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act, the Environmental Protection Agency gained authority to consider data submitted by one registrant to support the registration of pesticides by follow-on applicants, provided the applicant offers compensation to the original data submitter. If the parties fail to agree on the amount of compensation, either may initiate binding arbitration, and the arbitrator's findings are final except for review based on fraud, misrepresentation, or other misconduct. Appellees are thirteen large firms that had submitted research data to the EPA for pesticide registrations. After the 1978 amendments took effect, the firms filed suit in the Southern District of New York challenging the data-consideration and compensation provisions on constitutional grounds, later amending the complaint to include an Article III claim regarding the arbitration mechanism. The district court granted appellees' motion for summary judgment on their Article III claims. The District Court, rather than striking down the statutory limitation on judicial review, enjoined the entire FIFRA data use and compensation scheme. The Supreme Court vacated that judgment and remanded the case for reconsideration in light of its decision in Ruckelshaus v. Monsanto Co. On remand in this case, appellees amended their complaint to reflect that EPA had, in fact, considered their data in support of other registration applications. The amended complaint also alleged that data submitted by appellee Stauffer Chemical Company had been used in connection with registrations by PPG Industries, Inc., and Drexel Chemical Company. Stauffer had invoked the arbitration provisions of § 3(c)(1)(D)(ii) against PPG, and appellees entered in evidence the award of the arbitration panel, handed down on June 28, 1983. The district court reinstated its prior judgment enjoining the operation of the data-consideration provisions as violative of Article III. The Supreme Court noted probable jurisdiction on EPA's direct appeal.

In July 1997 the Administrator of the Environmental Protection Agency revised the national ambient air quality standards for particulate matter and ozone. American Trucking Associations, Inc., and its co-respondents, including the States of Michigan, Ohio, and West Virginia, challenged the new standards in the Court of Appeals for the District of Columbia Circuit pursuant to 42 U.S.C. § 7607(b)(1). The District of Columbia Circuit held that Section 109(b)(1) delegated legislative power to the Administrator in contravention of the Constitution because it provided no intelligible principle to guide the agency's exercise of authority. The court remanded the NAAQS to the agency for reconsideration. On rehearing the panel adhered to its position on the delegation point and on the implementation question, and it rejected the EPA's argument that the court lacked jurisdiction to reach the implementation question. The Administrator and the EPA petitioned the Supreme Court for review of the delegation, jurisdiction, and implementation questions. The respondents conditionally cross-petitioned for review of the costs question. The Supreme Court granted certiorari on both petitions in 2000 and consolidated the cases for decision. At the same time the EPA proposed the revised ozone NAAQS in 1996, it also proposed an interim implementation policy. After accepting comments, the White House published a memorandum prescribing implementation procedures, and the EPA announced in the preamble to its final ozone NAAQS that the provisions of subpart 1 of part D would apply to the implementation of the new standards.