The US House and Senate late Tuesday reached a consensus on a conglomeration of opioids legislation that will have far-reaching effects for the US Food and Drug Administration (FDA). Among the provisions that will affect FDA include allowing the agency to require prescription opioids to be packaged in a three- or seven-day blister packs, further collaboration with the Customs and Border Protection (CBP) to stop illegal opioids at the border, new public meetings and guid...

Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it. The 996-page bill includes major tweaks to the way in which the US Food and Drug Administration (FDA) regulates drugs, devices and biologics, while providing the agency with $500 million over 10 years to implement provisions that seek to move such products to patients more qu...

As House and Senate lawmakers race to approve a bill to fund the US government for 2016, the US Food and Drug Administration (FDA) should see a slight bump in discretionary funding of $132 million over last year. The proposed agreement, which is expected to face a vote on Friday, includes increases of $104.5 million for food safety related activities; $5 million for implementation of the Food and Drug Administration Safety and Innovation Act ( FDASIA ); $8.7 million for ...

Each year, legislators introduce dozens of pieces of legislation hoping to change how the US Food and Drug Administration (FDA) regulates pharmaceuticals, medical devices, biologics and dietary supplements. Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often. Can't find legislation you know exists...

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...

New legislation introduced last week in the House of Representatives would require greater gender equity in some clinical trials overseen by the US Food and Drug Administration (FDA). The bill, the Research for All Act , was previously introduced in 2014 by Reps. Jim Cooper (D-TN) and Cynthia Loomis (R-WO), and was reintroduced in the House on 29 April 2015. Background At its core, the bill aims to address something long known by regulators and medical research offi...

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...

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...

New legislation introduced in the US House of Representatives seeks a government investigation into the US Food and Drug Administration's (FDA) review of complex generic pharmaceuticals to consider whether the agency is in need of new regulatory authority. Background The bill, the Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 , was introduced on 24 March 2015 by Rep. Michael Burgess (R-TX), a former physician and member of the House Energy a...

New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite the review and approval of pharmaceutical products already approved in Europe. Background The bill, the Speeding Access to Already Approved Pharmaceutical Act , is sponsored by Reps. Tim Ryan (D-OH) and Steve Stivers (R-OH), who introduced the same bill in June 2014 . As with the original, the bill targets something known in th...