• Regulatory NewsRegulatory News

    Senators Reintroduce Bill to Make Pay-For-Delay Deals Illegal

    US Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) on Wednesday reintroduced a bill that would prevent branded and generic drug companies from forging deals that delay the launch of generics. The reintroduced  Preserve Access to Affordable Generics Act aims to increase consumers’ access to generic drugs by making the so-called pay-for-delay deals illegal. On average, pay-for-delay deals restrict access to generics by nearly 17 months, according to the senators. ...
  • Regulatory NewsRegulatory News

    Legal Analysis: FDA 'Pet Peeves' Could Lead to Bans on Drug Companies

    In 2012, the US Food and Drug Administration (FDA) was granted new authority to go after pharmaceutical companies that were, in its opinion, preventing regulators from fully inspecting drug and device manufacturing facilities. If a company way "delaying, denying, limiting or refusing" an FDA inspection, the law stated, FDA could deem a drug to be adulterated and prevent it from being sold. But as a new legal analysis finds, FDA has done little to define the difference be...
  • Regulatory NewsRegulatory News

    FDA Makes it Easier to Bring Generic Copies of Dangerous Drugs to Market

    A new draft policy issued by the US Food and Drug Administration (FDA) would makes changes to a complicated safety policy in the hopes of making it easier for generic drug manufacturers to make cheaper copies of dangerous drugs. Background To understand FDA's change, you need to understand quite a bit about REMS—Risk Evaluation and Mitigation Strategies. REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA) , and were meant to e...
  • GSK Investigated for 'Pay-for-Delay' Agreements in UK

    • 19 April 2013
    So-called "pay-for-delay" deals are nothing new for US pharmaceutical companies, where the practice of exchanging a payment in return for a set date of market entry (arguably later, hence the "delay") has seen increased use in recent years. Regulators, however, have never been particularly comfortable with the idea, saying the deals are anti-competitive and thus illegal under federal law. Now that idea is spreading, with UK trade regulators accusing several companies, mo...
  • Bill Seeks to End Pay-for-Delay Agreements

    A new piece of legislation introduced in the Senate would prohibit so-called "pay-for-delay" deals under the assumption that the deals delay the introduction of cheaper generic pharmaceutical medicines and are thus anti-competitive. Background The deals occur when a branded company and one or more generic companies settle patent litigation in such a way that the generic company agrees to delay introduction of its generic product for a period of time in return for a paym...
  • Senator Calls--Again--for White House to Release Sunshine Act Rules

    A prominent senator is once again calling upon federal officials to pass a long-delayed rule regarding the transparency of payments made by companies to healthcare providers, saying the delays are "unacceptable." Sen. Charles Grassley (R-IA), is the ranking Republican member of the Senate Committee on the Judiciary, and along with former Sen. Herb Kohl (D-WI) sponsored and wrote the Physician Payments Sunshine Act (Sunshine Act), which eventually became part of the 201...
  • FTC Report Indicates Pay-for-Delay Deals on the Rise

    The US Federal Trade Commission (FTC) has issued a new report regarding a review of 140 pharmaceutical patent disputes resolved in fiscal year (FY) 2012, noting that at least 40 of those agreements involve so-called "pay-for-delay" settlements in which a patent dispute is resolved mutually in return for the delayed entry of a generic competitor. Generic and branded pharmaceutical companies have long argued that the agreements are beneficial to all parties-taxpayers inc...
  • FTC Seeks Supreme Court's Intervention in 'Pay-for-Delay' Cases

    The US Federal Trade Commission (FTC) is calling on the US Supreme Court to review a so-called "pay-for-delay" case concerning generic and branded versions of AndroGel , a topical testosterone treatment, a new escalation in the agency's long-standing efforts to curb the practice. Pay-for-delay cases involve the manufacturer of a patented, innovative medicine paying its potential competitors not to manufacture generic versions of that medicine. FTC has consistently attac...
  • European Trade Regulators Charge Companies for 'Pay-for-Delay' Agreements

    • 26 July 2012
    If industry practitioners of so-called pay-for-delay settlements are worried about the climate for the legal agreements in the US after a recent court ruling against the measures, they should be just as concerned about European regulators, reports Reuters and The Financial Times . The agreements are commonly used by pharmaceutical manufacturers of branded products to delay the entry of generic competition in return for large cash payments or other forms of compensat...
  • Court: 'Pay-for-Delay' Practice Anticompetitive, Illegal

    In a potentially precedent-setting decision, a federal court has declared that payments made by companies to delay generic competition-also known as pay-for-delay settlements-are anti-competitive and illegal. The lawsuit, filed in the Third Circuit Court of Appeals in California, involved some of the pharmacy and pharmaceutical industry's largest companies, including CVS Pharmacy, Rite Aid, Walgreen, and Merck. The case was also supported by the Federal Trade Commissio...
  • House Version of user Fee Legislation Gets Major Boost from CBO

    What a difference a week and some amendments make. The Congressional Budget Office (CBO) has re-scored the House's amended version of the Food and Drug Administration Reform Act (FDARA) and has found that instead of costing taxpayers $250 million, it will now save taxpayers $370 million. The distinction is important, and not just because of the fiscal implications for taxpayers. Under legislation commonly known as PAYGO , any normal legislation found to add to the def...
  • BREAKING: After Gauntlet of Setbacks, Senate Passes Amended User Fee Bill

    • 24 May 2012
    BREAKING UPDATE: In a 96-1 vote, the US Senate has passed the Food and Drug Administration Safety and Innovation Act . The bill will now wait to be merged with the House of Representatives' version of the same legislation. Politico  has more on this piece of breaking news . ------------------------------------ After multiple days of political wrangling and an unexpectedly large number of amendments, the Food and Drug Administration Safety and Innovation Act ...