• Regulatory NewsRegulatory News

    Drug Counterfeiters Could Get Life in Prison Under New Bill

    New legislation introduced in the US House of Representatives just prior to the holiday break would amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to increase penalties on the sale or trade of counterfeit pharmaceuticals and also grant the US Food and Drug Administration (FDA) new authority to recall drugs. Counterfeit Bill Proposed The proposed legislation, The Counterfeit Drug Enforcement Act of 2014 , was introduced on 11 December 2014 by Rep. Steve Is...
  • Regulatory NewsRegulatory News

    In Transparency Move, FDA Makes its Enforcement Data Easier to View

    The US Food and Drug Administration (FDA) has just unveiled a new web-based tool intended to make it easier to dive into the agency's regulatory enforcement data. The tool, unveiled by Ann Ferriter, director of the Center for Devices and Radiological Health's (CDRH) Division of Analysis and Program Operations at the Regulatory Affairs Professionals Society's (RAPS) The Regulatory Convergence conference this week, is meant to simplify regulatory intelligence for res...
  • Feature ArticlesFeature Articles

    DTC Broadcast Advertisements: The Evolution of Major Statements

    Direct-to-consumer (“DTC”) advertising has a long, robust regulatory history, mostly rooted in debates over the pros and cons of promoting a prescription drug directly to consumers. 1 Critics have issued various condemnations about DTC, contending that DTC advertisements, to name a few concerns, increase drug costs, misinform patients rather than educate them, overemphasize a drug’s benefits, and minimize risk information by limiting the amount of drug risks included, pr...
  • Regulatory NewsRegulatory News

    After New Drugs Delayed by DEA, Legislators Seek Overhaul of Drug Scheduling Process

    For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA ) , the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs. Now new legislation wants to make the process by which DEA ...
  • Facing Dire Shortage of IV Saline, FDA Again Turns to Enforcement Discretion Approach

    In the face of mounting concerns about a shortage of intravenous saline solutions, the US Food and Drug Administration (FDA) announced it is once again utilizing an uncommon regulatory mechanism to ease the shortage-a mechanism no longer on the strongest of legal footings. Background Drug shortages have been an ongoing problem in the US since at least 2011, and have been blamed on a number of causes, including quality problems at manufacturing facilities, overly aggr...
  • FDA Offers New Ideas for Transparent Approach Toward Regulatory Enforcement

    Here at Focus , we read regulatory enforcement documents like it's our job. To be fair, understanding what the US Food and Drug Administration (FDA) is doing and why is our job. But despite having read through thousands of Warning Letters, recall notices, Form-483s and other enforcement notices, we can say one thing with relatively certainty: It's never been easy to track down everything FDA does. Information: Hard to Find, Hard to Process Some of its enforcement...
  • DOJ Says Corporate Integrity Agreements Are Cornerstone of New Compliance Approach

    The pharmaceutical industry's reputation has been heavily battered over the course of the last two decades, in part because of a seemingly endless stream of massive multibillion-dollar settlements over charges of off-label marketing claims. Those fines, which have seemingly done little to curb illicit behavior, have been seen by at least some industry analysts as cost of doing business-not a deterrent. But the Department of Justice (DOJ) seems poised to change that dyn...
  • Shutdown Leads to New Record Low for FDA Warning Letters

    Regular watchers of the US Food and Drug Administration (FDA) know one thing about Tuesdays: It's Warning Letter day, the weekly Christmas for those who take enjoyment from reading through occasionally arcane enforcement and advertising policy. For some-and we count ourselves among them-FDA's Warning Letter postings are a regular source of the alarming and interesting, often in equal measure. But these past two weeks have been anything but regular. Since 1 October 20...
  • Shortages Ongoing and Import Approach in Legal Jeopardy, FDA Turns to Expedited Approvals

    Despite the US Food and Drug Administration's (FDA) ongoing efforts, the problem of drug shortages is persisting with a stubborn tenacity, particularly in several high-need areas. But with its existing method of alleviating drug shortages in legal jeopardy, FDA now seems to be adopting a more permanent tactic to confronting some shortages: full and expedited approvals. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injecta...
  • Feature ArticlesFeature Articles

    What Can You Say?: Uncovering Trends in Recent Medical Device Enforcement Actions

    Due to multi-million-dollar (and sometimes billion-dollar) settlements, the vast majority of headlines regarding off-label promotion cases in recent years have involved drugs. Although less prominent, the US Food and Drug Administration (FDA) has steadily continued to act against medical device manufacturers for the same conduct, mostly in the form of Warning Letters. Between 1 May 2012, and 30 April 2013, FDA's Center for Devices and Radiological Health issued 24 Warning...
  • New Compliance Guide Calls on Veterinary Food Manufacturers to Adhere to Good Practices

    The US Food and Drug Administration (FDA) has announced the release of a new draft compliance policy guide (CPG) regarding the labeling and marketing of veterinary food products intended for use in canine and feline species. The CPG is intended to broadcast the agency's anticipated use of its enforcement discretion for products that are specifically intended to diagnose, treat, cure or prevent disease in the two species. FDA said its Center for Veterinary Medicine (CVM) ...
  • Blaming FDA's Enforcement Discretion, Company Files for Bankruptcy

    Missouri-based KV Pharmaceutical , the manufacturer of pre-term birth prevention compound Makena (hydroprogesterone caproate injection), has filed for bankruptcy in federal court citing the US Food and Drug Administration's (FDA) "lack of enforcement" of the company's marketing exclusivity rights, reports Bloomberg . The filing could mark a final chapter in a long-running and often controversial saga between KV and FDA. The entire matter stems FDA's 2011 approva...