On Tuesday, June 4, 2013, FDA made available for comment a proposal to make available to the public, de-identified and masked clinical and preclinical data contained in product applications submitted to the agency. To see the Federal Register notice (the “Notice”), click here. FDA explains that the impetus for this proposal is to improve the efficiency… Continue Reading
On May 28, 2013, FDA issued a draft guidance for industry, titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. The release of this draft guidance is important because, although it has long been common practice for drug companies to contract with third parties to perform parts of the manufacturing process (such as formulation, analytical testing, packaging, and labeling) or in some cases, to perform all of the manufacturing process, FDA previously had provided only limited guidance on the issues that the agreements establishing these arrangements should address. The newly-released agency document provides guidance on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in contract manufacturing of drugs.
French Decree n°2013-414 dated 21 May 2013 implementing the French Sunshine regulations was published in the Official Journal of 22 May 2013 (the “Decree”). The Sunshine regulations were introduced to French law pursuant to a law dated 29 December 2011 (aka. Bertrand law) setting out the obligation for enterprises working in the health sector to publish benefits granted and agreements entered into with several players in the health sector, including healthcare professionals.
The Food and Administration’s (FDA’s) Office of Prescription Drug Promotion (“OPDP”) issued an enforcement letter to CBA Research, Inc., on April 25, 2013 regarding improper promotion of its investigational new drug CBT-1® (tetrandrine) Capsule (“CBT-1”). According to OPDP, the company’s website misleadingly promoted the investigational new drug as safe and effective and overstated its efficacy. … Continue Reading
As of 10 April 2013, the transparency register regarding financial relations between pharmaceutical companies and healthcare professionals in the Netherlands will go live. Through the register, anybody from patients and journalists to competitors will be able to search per healthcare professional or per organization of healthcare professionals for financial relations with pharmaceutical industry. The self-regulatory… Continue Reading
On March 13, 2013, FDA announced in the Federal Register the availability of an FDA draft guidance, titled “Formal Dispute Resolution: Appeals Above the Division Level.” Formal dispute resolution affords sponsors a mechanism by which they can appeal scientific and procedural decisions by FDA. For human drug applications under PDUFA, FDA’s performance goal is to… Continue Reading
On 7 March 2013, the European Commission adopted a black triangle as the symbol to be placed on the patient information leaflets and the Summary of Product Characteristics (“SmPC”) of medicinal products “subject to additional monitoring” in the European Union (“EU”). The history of the black triangle The requirement to include a black symbol in… Continue Reading
A three-judge panel of the Court of Appeals for the Ninth Circuit has affirmed the conviction and sentence of W. Scott Harkonen, M.D., former CEO of InterMune. Dr. Harkonen was accused of directing his staff to issue a press release for the drug Actimmune regarding the results of a Phase III study in an unapproved… Continue Reading
We’ve received a number of questions lately about the status of the sample reporting requirements under Section 6004 of the Affordable Care Act (ACA) of 2010. Section 6004 requires that manufacturers and authorized distributors submit certain information about drug sample distribution to FDA: (1) the identity and quantity of drug samples requested; (2) the identity… Continue Reading
The following is a summary of some of the key issues Congress and the Administration will be debating in 2013. Please contact us with any questions. We are happy to provide further analysis as well as insight into other areas of interest. Agriculture: Tom Vilsack is expected to stay on as Secretary of Agriculture…. Continue Reading
Final Rule on Combination Product cGMP FDA today announced the release of a final rule on current good manufacturing practices (cGMP) for combination products. The rule, which will establish 21 CFR Part 4 – Regulation of Combination Products, is set for publication in the January 22 edition of the Federal Register, and will become effective… Continue Reading
Topics discussed at the recent Food & Drug Law Institute’s (FDLI) Enforcement, Litigation and Compliance Conference included FDA Center leaders’ enforcement priorities, interagency enforcement actions, the implications of increasing globalization, and the diversion of controlled substances. Among the highlights: Joseph Rannazzisi, Deputy Assistant Administrator in DEA’s Office of Diversion Control, said due diligence is the… Continue Reading
On December 3, 2012, the Court of Appeals for the Second Circuit issued an opinion in the matter of United States v. Caronia, which has received substantial attention in the national and pharmaceutical trade press. Hogan Lovells’ analysis of that opinion and its potential implications is available here.
On 6 December 2012, the Court of Justice of the European Union (“CJEU”) handed down the final chapter in the long-running AstraZeneca case (Case C-457/10P, AstraZeneca v European Commission). Whilst the CJEU refrained from establishing a detailed test for when conduct before a patent office can constitute an abuse of a dominant position, it confirmed that misuse of regulatory procedures… Continue Reading
Recently, industry leaders, members of the FDA bar, and government officials convened at the Food & Drug Law Institute’s (FDLI’s) Advertising & Promotion Conference and the Pharmaceutical & Regulatory Compliance Congress. Topics included policy updates and enforcement priorities from FDA’s centers, Office of Inspector General (OIG) and Department of Justice (DOJ) current and future enforcement… Continue Reading
The FTC recently took action to enforce a subpoena against a pharmaceutical company related to its investigation into the firm’s settlement of patent litigation. Pharma companies are likely familiar with the FTC’s intent to stop patent settlements that it believes involve payments from the brand to the generic in exchange for delaying entry of the… Continue Reading
For sponsors developing new chemical structures based on previously approved active ingredients, two new FDA decisions offer a clear – though hardly satisfying – standard for determining whether a new structure will be awarded 5-year “new chemical entity” (NCE) exclusivity. In two letter decisions issued on the same day, the agency firmly explained that NCE… Continue Reading
Each of the 500 largest businesses in America has been asked by the Senate Commerce Committee to describe how it deals with cybersecurity, demonstrating that government’s focus on cybersecurity is not going away despite stalled legislative efforts. On 19 September, Senator Jay Rockefeller (D-WV) sent an unprecedented letter to the chief executives of the 500 largest companies… Continue Reading
On August 30, 2012, Janssen Pharmaceuticals, Inc. (“Janssen”) and its parent company, Johnson & Johnson, agreed to pay $181 million to 37 states and the District of Columbia to settle allegations that the marketing and advertising of its atypical antipsychotic products (Risperdal, Risperdal Consta, Risperdal M-Tab, and Invega) violated state consumer protection laws. The settlement imposes… Continue Reading
The FTC has proposed a change to the Hart-Scott-Rodino filing requirements relating to acquisitions of exclusive patent rights in the pharmaceutical industry. The proposed rule would extend the circumstances under which the transfer of exclusive patent rights for pharmaceuticals would be subject to HSR reporting requirements. Under present rules, the transfer of exclusive rights to… Continue Reading
As part of FDA’s continuing efforts to complete its Drug Efficacy Study Implementation (DESI) review, FDA published a July 24, 2012, Federal Register notice offering companies an opportunity to affirm hearings related to certain DESI dockets. The companies have 30 days to respond to FDA or else FDA will deem the hearing requests to be… Continue Reading
To update our previous post on this subject, on July 20, 2012, the government filed its brief opposing KV’s request for injunctive relief and moved to dismiss the case. In its brief, the government argues that KV lacks standing to sue because, in June 2012—prior to KV filing suit—the agency posted on its website a statement and a… Continue Reading
K-V Pharmaceutical Company (“KV”) and its wholly-owned subsidiary, Ther-Rx Corporation (“Ther-Rx”) filed suit in the U.S. District Court for the District of Columbia on July 5, 2012 against the FDA seeking declaratory and injunctive relief to “restore” KV’s 7-year orphan drug exclusivity for MAKENA (hydroxyprogesterone caproate or 17P) Injection, 250 mg/mL.
On 5 July 2012, Medicines Australia, the pharmaceutical industry association in Australia, announced the adoption of its new Code of Conduct. Although the Code is not legally binding, it reflects a growing tendency, partly legislative in nature and partly through industry self-regulation, to promote transparency in relationships between the pharmaceutical industry and healthcare professionals and… Continue Reading