Regulierung und Compliance in der pharmazeutischen Industrie
Chambers USA 2018, Client Reference
Experienced Counsel to Guide You Through Industry Growth
Whether you’re a life sciences industry giant or a startup, changes to cybersecurity, pharmaceuticals, medical devices, patient rights and transformative ventures present great opportunities for industry growth, but also new—and sometimes daunting—challenges for your organization. Intense financial penalties, negative rulings and individual accountability are only a few of the risks life sciences companies face if they do not understand and remain compliant with these ever-changing regulations.
McDermott’s global team of regulatory lawyers work with you to create and implement practical plans to anticipate and mitigate potential risks; respond to inquiries by state, national and international agencies; and, if necessary, pursue resolution of disputes in court and before administrative and other tribunals in a way that least disrupts your business.
Our mission-first approach, coupled with proven experience, helps drive the success of your initiatives:
Obtaining antitrust and other approvals for acquisitions and licensing
Clinical trial development
Product application and review
Manufacture, marketing and reimbursement of drug, biologic, device and other products
US Food and Drug Administration (FDA) review
Good Manufacturing Practice (cGMP)
Advertising and promotion
Supply chain and distribution, including pricing programs
Internal compliance program implementation and monitoring
Resolution of issues arising from clinical trial oversight
Inspections, compliance and enforcement investigations and actions of the FDA, US Department of Justice (DOJ), other federal and state agencies, and Congress, as well as qui tam and other litigation
Our global team of top lawyers combines the market intelligence and proven experience of our Tier 1 health practice with our deep bench of lawyers from our FDA; food, beverage and agribusiness; antitrust; environmental; corporate and securities; and other core practices. Working together, we help clear your path to success.
Amgen in securing antitrust clearance for its $10.4 billion acquisition of Onyx Pharmaceuticals, a global biopharmaceutical company engaged in the development and commercialization of therapies for cancer patients, in Amgen’s largest deal to date
Amgen in securing antitrust clearance for its $315 million acquisition of KAI Pharmaceuticals
Amgen in all aspects of one of the largest biotechnology cases to go to trial, in which Hoffman La Roche sought to break the six Lin patents that had secured Amgen’s monopoly in the United States
A global health care leader with securing merger control clearance from the Chinese government for its merger with one of the world’s largest pharmaceutical companies capable only because of the Firm’s ability to negotiate directly with regulatory authorities because of MWE China’s PRC license
A pharmaceutical company in federal and state False Claims Act investigations relating to Medicaid
Prepared draft guidance submitted by PhRMA to FDA on Section 114 promotional use of health care economic data, and worked with many pharmaceutical and biotechnology companies on their formulary submission packages (Academy of Managed Care Pharmacy dossiers) and economic analyses presentations
Abbott Laboratories on a broad range of government affairs, reimbursement, and regulatory policy initiatives across their portfolio of products.
Successfully obtained reconsideration for the payment rate for procalcitonin, a novel test to assess for risk of acute sepsis
Secured payment reform for advanced diagnostic test under a 2 year Medicare demonstration program which was enacted under the Affordable Care Act as a result of our lobbying efforts for a key coalition client