Sunshine Laws & External Reporting
Sunshine is the best disinfectant, and oftentimes that phrase is applied to the opening of government to stave off corruption. Yet the phrasing has become part of the regulatory culture for pharmaceutical companies, requiring reporting and disclosure from these companies to stave off improper pricing schemes on the public.
Federal law and some state governments require disclosure of funds paid to physicians from healthcare manufacturers. Life Law Partners can assist by providing the technology and structure necessary to track these forms of disbursements and by preparing and submitting necessary reporting that complies with the relevant laws for where you operate.
Pricing Reporting & Transparency
Federal law and, given recent developments, some state and local governments require price disclosure and transparency for pharmaceuticals sold to government-sponsored healthcare programs, including average manufacturer price (AMP) reporting, average sales price (ASP) reporting and state-level price transparency reporting. Life Law Partners can assist by assessing whether these reporting and transparency requirements apply to your operations and locations and by assisting with the proper calculation and reporting of these pricing values to the relevant agencies, all under the backdrop of protecting your propriety information from public disclosure.
Life-science companies have reporting obligations with their products, especially when it comes to safety, even after FDA approval. Life Law Partners can assist necessary reporting to the FDA and other agencies when safety issues arise, including through adverse events monitoring, field alert reports and periodic reporting of safety matters and manufacturing concerns to relevant public agencies, as required.
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