• Citing Confidentiality Troubles, Mystery Firm Petitions FDA to Delay Posting of Warning Letter

    The story has it all: Mystery, intrigue, failures and secrecy. But it's not the latest plot line for a mystery novel-it's the latest out of the US Food and Drug Administration's (FDA) federal register docket, where a prominent life sciences law firm has petitioned the agency to hold off on posting a warning letter to an unidentified pharmaceutical company it represents. Background The petition for a stay of action-in plain parlance, a request to delay an action-was made...
  • Citing Public Health Needs, FDA Alters Labeling Standards for Smoking Cessation Products

    The US Food and Drug Administration (FDA) has, in response to three citizen petitions submitted to the agency, agreed to modify the labeling of nicotine replacement therapies (NRT) to indicate that consumers are allowed to use other NRTs and infrequently smoke when attempting to quit smoking using an NRT. Background Nicotine replacement products have been on the US market for nearly three decades, and are commonly used to wean users of tobacco products off the substance...
  • Groups Call on FDA to End Transparency Policy They Say Violates Spirit, Letter of Law

    The way in which the US Food and Drug Administration's (FDA) treats some Freedom of Information Act (FOIA) requests-the primary method of extracting non-publicly available information from an agency-has angered more governmental transparency advocates, who say the agency needs to stop its use of a so-called "minor deletion" policy it says is preventing groups from appealing adverse FOIA decisions. Background The policy of "minor deletions" is essentially a loophole in...
  • FDA Will Continue to Allow Unapproved Drugs to Receive National Drug Code Numbers

    The US Food and Drug Administration (FDA) will continue to grant national drug code (NDC) numbers to pharmaceutical and other drug products not explicitly approved by FDA for a given indication after rejecting a Citizen Petition from Susan Alpert, RAC. Background NDCs were created in 1969 as a response to the difficulties of processing claims in the absence of a standardized product identification system for drug products. The NDCs were intended to provide "an identific...
  • FDA Now Able to Temporarily Approve Generic Drugs Using Different Label than RLD

    The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), part of its Center for Drug Evaluation and Research (CDER), is out with the new policy that aims to clarify how its staff should implement a relatively new statutory provision that permits the agency to approve generic drugs even when labeling changes are happening with  its comparator product, the reference listed drug (RLD). Background The section in question, 505(j)(10) of the Federal Fo...
  • Group Calls for REMS-Like Conditions for Popular Hypertension Drugs

    The public safety advocacy group Public Citizen is calling on the US Food and Drug Administration (FDA) to place additional safety warnings and restrictions on several classes of hypertension drugs due to safety concerns. In a petition sent to FDA Commissioner Margaret Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock on 4 October, Public Citizen said three types of hypertension drugs-angiotensin-converting enzyme (ACE) inhibitors, angiotensin...
  • Group: FDA's Interpretation of FOIA Procedures Illegal

    The public health advocacy group Public Citizen is blasting the US Food and Drug Administration (FDA) for its application of the Freedom of Information Act (FOIA) , saying in a statement that the agency's actions violate both the "letter and spirit" of the law. FOIA , passed in 1966, has been dramatically expanded over the last half century to include numerous provisions requiring federal agencies to release documents relating to many internal decision-making proce...
  • GPhA: 505(j) Provisions Saved US $1 Trillion Since 2002

    Abbreviated new drug applications-also known as generic drug applications or 505(j) applications-have saved US citizens more than a trillion dollars in the past decade, says a new report out from the health data analytics firm IMS Health and sponsored by the Generic Pharmaceutical Association (GPhA). The report, " Savings: $1 Trillion Over 10 Years ," comes as healthcare costs continue to rise, outpacing inflation on a consistent basis. Generic medicines, says the repo...
  • Proposed Legislation Overhauls Regulatory Environment for Tamper-resistant Opioids

    A new piece of legislation proposed in the US House of Representatives would provide pharmaceutical manufacturers with incentives to develop tamper-resistant products by changing the rules of the competitive landscape. The Stop Tampering of Prescription Pills Act of 2012 , introduced by Rep. Bill Keating (D-MA) on 19 July, would first amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to include a definition for "tamper-resistant drug[s]." Such a product ...
  • FDA Backs HIV Prevention Drug In Letter Denying Citizen Petition

    The US Food and Drug Administration (FDA) this week published a citizen petition denial to a group seeking to pre-emptively block the approval of a supplemental New Drug Application (sNDA) for Gilead Sciences' Truvada for preventing the transmission of HIV-1. The group, the AIDS Healthcare Foundation (AHF), had filed the petition on 7 March 2012-part of a subsequent campaign by the group to call attention to the drug. In a series of advertisements, AHF asked, "What rotte...
  • Bill Introduced to Speed Development and Review of Breakthrough Therapies

    A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new "breakthrough therapy" designation at the US Food and Drug Administration (FDA). The bill, To amend chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the development and review of breakthrough therapies , would amend the FD&C Act  to include pr...
  • Supreme Court Rules Company Can Sue Novo Nordisk For Delaying Generic Medication

    • 18 April 2012
    The Supreme Court of the United States ruled 17 April that Caraco Pharmaceuticals can proceed with a lawsuit against Novo Nordisk over Nordisk's purported attempts to prevent Caraco's generic entry into the market, reports various news sources. "At issue was the ability of a brand-name drugmaker to block generic competition by providing the US Food and Drug Administration (FDA) with overly broad descriptions of its patents," writes  Pharmalot . Caraco's lawsuit a...