In 2014, enforcement actions related to the Foreign Corrupt Practices Act (FCPA ) generated fines totaling more than $1.5 billion with the average corporate penalty exceeding $156 million. Also in 2014, the US Department of Justice (DOJ) announced it would hire an additional 300 agents to focus solely on FCPA investigations and enforcement. On 3 March 2015, the director of the Division of Enforcement of the Securities and Exchange Commission (SEC) stated, “…in 2015, th...

Under Section 6002 of the Patient Protection and Affordable Care Act (commonly referred to as the Sunshine Act ), data must be reported to the Centers for Medicare and Medicaid Services (CMS) by pharmaceutical and medical device manufacturers regarding promotional, research, consulting and other support activities. 1 These data tell a very public story about those activities and the recipients of any fees or transfers of value behind them. Unfortunately, negative pu...

The US Food and Drug Administration (FDA) is kicking off the reauthorization process for the Medical Device User Fee Act (MDUFA), a program which funds a significant portion of its medical device regulatory review activities. Background FDA's user fee program began with the passage of the Prescription Drug User Fee Act (PDUFA) in 1992. The law, originally intended to speed up the regulatory review process, wound up being so popular that it inspired several other user ...

A revised version of the 21st Century Cures Act , a bill being considered by the House Energy and Commerce (E&C) Committee, would allow medical device manufacturers to leverage third-party auditors to assess the state of their quality manufacturing systems. The measure, contained within the "Medical Device Regulatory Process Improvements" section of the bill, was first introduced in the original draft of the 21st Century Cures Act , but was removed without expla...

An updated draft of the House Energy and Commerce (E&C) Committee's 21st Century Cures Act has reintroduced a provision which would extend marketing exclusivity for some drugs repurposed to treat rare diseases or conditions by six months. Background The provision, popularly known as the Orphan Product Extensions Now Act , was originally introduced in the US House of Representatives in November 2014. Under the bill, existing pharmaceutical products would be grant...

The US Department of Health and Human Services (HHS) has unveiled new regulations to establish a parallel system of organ donation intended to serve patients with the human immunodeficiency virus (HIV). Background The regulations come almost a year and a half after US President Barack Obama signed into law the HIV Organ Policy Equity (HOPE) Act of 2013 . The law, passed in November 2013, modified the National Organ Transplant Act (NOTA) of 1984 by permitting HIV-p...

The US Food and Drug Administration (FDA) is a reasonable regulator. That's the conclusion of a new analysis looking at the measures taken by FDA to review and approve new drugs intended for use in rare diseases affecting small populations of patients. Background The root of this "reasonable" argument starts with a law intended to facilitate the development of new therapies for patients with rare diseases. Under the 1983 Orphan Drug Act , a rare disease is one which a...

The US House Energy and Commerce (E&C) Committee has released an updated draft of a piece of legislation which proposes dramatically overhauling the way in which the US Food and Drug Administration (FDA) regulates many healthcare products. The bill, the 21st Century Cures Act , has been under development since at least April 2014, when the E&C Committee kicked off its "21st Century Cures Initiative." The initiative is intended to speed up the pace at which FDA approve...

Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way. Background On 24 April 2015, Sens. Richard Burr (R-NC), Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced the Advancing Breakthrough Devices for Patients Act ( ABDP Act ) . As written, the law is heavily based on the "breakthrough therapies" section ( Section 902 ) of th...

The US Department of Health and Human Services (DHHS) says it will shield the manufacturer of the investigational Ebola virus treatment ZMapp from legal liability under a federal law intended to incentivize the development of new medical products for medical emergencies. Background Under emergency scenarios—the outbreak of a new disease or a disaster—federal legislation permits the US Food and Drug Administration (FDA) to authorize the use of new medications and medical...

Congressional legislators are preparing to unveil the next iteration of the 21st Century Cures Act , a massive piece of draft legislation intended to overhaul the way in which the US Food and Drug Administration (FDA) regulates and incentivizes the development of new medical products. Background The legislation was first unveiled in January 2015 after months of discussions between legislators, regulators, industry, innovators, academics and patients. As extensively e...

Regulators and generic pharmaceutical companies, start your engines. The race to the next reauthorization of the Generic Drug User Fee Act (GDUFA) has begun. In a Federal Register notice on 21 April 2015, the US Food and Drug Administration (FDA) announced that it will begin accepting comments regarding the first-ever reauthorization of GDUFA—a user fee arrangement which funds much of FDA's generic pharmaceutical regulatory activities. Background GDUFA was first pa...