Drugs have a limited shelf life. Businesses don't. Hinshaw helps clients succeed over the long term.
Today's pharmaceuticals are more effective—and more complex—than ever. The same is true for the pharmaceutical and pharmacy industries. Drug companies and individual pharmacists alike can have a tremendous, positive impact on the lives and health of their patients. But the regulatory hurdles they must leap and the financial and businesses challenges they must overcome often seem to complicate, rather than simplify, the path toward success.
At Hinshaw, we know that effective legal counsel is like good medicine: it must be offered at the right time and in the right amount. Our health care lawyers have experience advising a broad range of industry clients—from individual pharmacists and small business owners providing one-on-one patient care—to major, multinational pharmaceutical companies whose research into innovative drugs and treatment protocols will have lasting, global effects.
We serve pharmaceutical clients throughout the lifecycle, beginning with basic research and clinical trials, through marketing and distribution, to prescription and sale. Our lawyers understand the regulatory, legal and business issues that arise at each of these steps and provide effective counsel that helps resolve immediate challenges while also setting the stage for future success. We advise clients on the following:
- Research and drug trials
- Patents, trade secrets, and other IP prosecution and enforcement
- Licensure, operations and regulatory compliance
- Medicare Advantage and Part D Program requirements, including reimbursements and pricing
- HIPAA, HITECH Act, and related federal and state data privacy and security requirements
- Mergers, acquisitions, joint ventures and other business transactions
- Board disciplinary administrative complaints and administrative hearings
- Drug Enforcement Agency (DEA) matters
- Payor audit appeals and investigation defense
- Audits and internal investigations
- Professional and product liability defense
Our experienced health care litigators also counsel clients in the full range of commercial disputes. We provide outcome-driven representation, whether negotiating across the settlement table or presenting a strong defense in court.
- Attention Pharmacies and Prescribers: New California Controlled Substances Prescription Form and CURES Reporting Requirements Are ComingNovember 19, 2020Health Care Alert
- California Board of Pharmacy Approves "No Pharmacist Left Alone" Regulations for Retail Pharmacy ChainsSeptember 21, 2020Health Care Alert
- August 26, 2020Health Care Alert
- OPA Program Update 2020 Highlights Changes to 340B Program Registration and Recertification RequirementsAugust 13, 2020Health Care Alert
- May 14, 2020Health Care Alert