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  • Regulatory NewsRegulatory News

    Bill Would Benefit Developers of Drugs for Rare Diseases

    A new bill introduced in the US House of Representatives would grant existing pharmaceutical products an additional six months of marketing exclusivity if a company is able to demonstrate the product is able to treat or prevent a rare disease or condition. Background The bill, the Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 (OPEN ACT), appears to be loosely modeled off a similar plan in place for pediatric products. Under the US Food a...
  • Regulatory NewsRegulatory News

    Bill to Speed up Approvals for Sunscreen Ingredients, Other Drugs Awaits Obama's Signature

    US legislators in the House of Representatives have passed a Senate bill which would overhaul the manner in which the US Food and Drug Administration (FDA) approves sunscreen ingredients and other products through a rarely used regulatory pathway known as the Time-and-Extent process (TEA), all but assuring the bill will be passed into law. Background The bill, known as the Sunscreen Innovation Act (SIA) , follows extensive complaints by several companies that their sun...
  • Regulatory NewsRegulatory News

    Senate Bill Seeks Faster, More Predictable Approvals for Time and Extent Applications

    Senate legislators have released a new iteration of the Sunscreen Innovation Act , a bill which seeks to accelerate the approval of long-delayed new sunscreen ingredients in the US, which would go beyond sunscreen ingredients to overhaul part of the process used to approve over-the-counter (OTC) drugs. Background As explained in our article on the House version of the Sunscreen Innovation Act , the bill has long been focused on the Time and Extent (TEA) application ...
  • Regulatory NewsRegulatory News

    House Legislators Clear Sunscreen Innovation Bill, but Questions Remain

    The US House of Representatives has voted in favor of a bill that would require the US Food and Drug Administration (FDA) to speed up its assessment process for new sunscreen ingredients that have been awaiting regulatory approval for as long as a decade in some cases. Background The bill, the Sunscreen Innovation Act (H.R. 4250) requires FDA legislators to speed up their review of sunscreen ingredients submitted under the Time-and-Extent Application (TEA) process. ...
  • Regulatory NewsRegulatory News

    Bill Would Expedite FDA Approvals for Drugs, Devices Given OK by EU Regulators

    When the US Food and Drug Administration (FDA) approves a drug, its primary concern is with the product's safety, efficacy and quality. But a secondary concern is what is known as "drug lag"—the time between when a product was first approved for use elsewhere in the world and when it was approved in the US. Background: Drug Lag The issue of drug lag was once a major concern in the US, which largely lagged behind the EU in drug approvals, but has largely fallen int...
  • Legislators Seek New Regulatory Tools, Framework for Regenerative Medicine

    New legislation introduced in the House of Representatives this week seeks to develop a comprehensive framework capable of allowing the "rapid approval" of regenerative medicine products by the US Food and Drug Administration (FDA). While the bill, the Regenerative Medicine Promotion Act (RMPA) of 2014 , does not define the term "Regenerative medicine," it is defined by the National Institutes of Health as, "the process of creating living, functional tissues to repair...
  • Bill Aims to Speed up Regulatory Process for Abuse-Prone Drugs

    A new piece of legislation introduced today by a bipartisan congressional duo calls for the improvement of a current regulatory stumbling block that some companies have likened to a "black hole." Background While the US Food and Drug Administration (FDA) determines whether a drug is safe and effective in the US, the determination of whether its component parts are addictive or prone to abuse falls under the authority of the US Drug Enforcement Administration (DEA) and t...
  • Bill Would Create Incentives to Seek New Approvals for Old Biologics

    A new bill introduced in the US House of Representatives on 24 March 2014 would grant companies additional patent protections for repurposed biological products. Bill Basics The bill, the Independent Innovator and Repurposing Act (IIRA) , is cosponsored by Reps. Joaquin Castro (D-TX) and Randy Forbes (R-VA) and is intended to provide "appropriate intellectual property protections" for some products. Those products, the bill explains, are any biologicals regulated un...
  • FDA to Get Access to New Funding, Sequestered User Fees Under New Spending Bill

    The holiday season may technically be over, but the US Congress is poised to give the US Food and Drug Administration (FDA) a long-sought and large gift in the coming weeks: Access to approximately $85 million in sequestered user fee funding and more than $90 million in new funding. Background: Sequestered User Fees FDA was authorized to collect the funds under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) , but its authority to spend the fun...
  • Hearing on FDA Appropriations Finds Usual Supporters Voting Against the Agency's Budget

    The US Food and Drug Administration (FDA) is, first and foremost, a regulatory agency charged with overseeing the safety, efficacy and quality of healthcare and other consumer products. But it is also an agency that frequently finds itself at the nexus of political battles, such as this week when its appropriations were put to a vote in the US House of Representatives, leading to a bizarre political debate. Background The US government has been "shut down" since 1 Octob...
  • Legislation Seeks Creation of Commission to Overhaul Federal Regulations

    New legislation introduced in the US Senate seeks to establish a legislative commission to collect input on federal regulations, with the goal of eventually streamlining, consolidating and repealing regulations that are seen as inefficient, redundant or ineffective. The Regulatory Improvement Act The legislation, the Regulatory Improvement Act (RIA) of 2013 , calls for the creation of a "Regulatory Improvement Commission," would specifically target regulations that...
  • Obama Signs New FDA User Fee Bill for Veterinary Pharmaceuticals Into Law

    US President Barack Obama has signed into law a new piece of legislation that is set to increase the amount of funding given to the US Food and Drug Administration (FDA) by the veterinary pharmaceutical industry in the hopes of speeding up review and clearance times for product applications. Background The legislation, known as the  Animal Drug and Animal Generic Drug User Fee Reauthorization Act (ADAGDUFRA) , is an amalgamation of the Animal Drug User Fee A...