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Brand-new FDA guidelines have created a long-awaited shortcut
for bringing biosimilars—cheaper versions of biologically
derived pharmaceuticals—to the U.S. market. But the
pathway won't be nearly as straightforward as the one for
generic versions of less complex, chemically based drugs that was
created under the Hatch-Waxman Act in 1984.
Unlike the Hatch-Waxman route, the biosimilar guidelines issued
in February call for drug makers to be in regular contact with the
FDA during virtually every step of the development process,
explains Morrison & Foerster attorney Cary Miller. Many
decisions will be made on a case-by-case basis. "I think the
approval process will evolve as companies develop their
products," she says.
"The uncertainties associated with the new process could
spur companies to forgo it in favor of the traditional licensing
process," adds Stephanie Hsieh, former Of Counsel at Morrison
& Foerster. Some have also raised concerns about the amount of
confidential information an applicant might have to disclose
through the new process.
Despite the difficulties, it appears that many companies will
press on with biosimilars efforts. One research firm has estimated
that U.S. sales of biosimilars could reach $8 billion by 2020.
Because of the generality of this update, the information
provided herein may not be applicable in all situations and should
not be acted upon without specific legal advice based on particular
situations.
Whether you are an employer that provides health insurance for your employees, a business in the growing healthcare industry, a hospital, or other medical provider—or you provide services to any of those entities—you need to know about changes to the privacy and security rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Understanding the complexities of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules is often a challenge for health care providers and consumers.
Marilyn Tavenner received bipartisan support from members of the Senate Committee on Finance in her confirmation hearing to lead the Centers for Medicare and Medicaid Services (CMS) though a full Senate vote is being held up, the president released his FY 2014 budget proposal with health care reform and specified reimbursement reductions to providers and manufacturers totaling $400 billion over 10 years sprinkled throughout it, and Department of Health and Human Services (HHS) Secretary Sebelius
The Office of Inspector General for the Department of Health and Human Services has recently issued an updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs.
On Tuesday, the North Carolina legislature has enacted into law, pending the governor's signature, a prohibition on the use of most favored nations clauses in contracts between commercial health insurers and providers.
Discussing Myriad & The Supreme Court With LXBN TV
