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Draft Proposals for Public Comment

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Introduction

Transparency Report Arrow Draft Proposals for Public Comment


Draft Proposals for Public Comment

The draft proposals for public comment are organized in alphabetical order by topic. 

 

Adverse Event Reports 
For certain FDA-regulated products, FDA provides a mechanism for the public to quickly access public information from adverse event reports submitted to the Agency.  Even where provided, however, such information is not now always accessible in a manner that allows users to generate summary reports of this information.

The Task Force proposes for public comment:

  1. FDA should expand the areas in which it provides the public with online access to public information from adverse event reports about FDA-regulated products submitted to FDA, in a format that is searchable and allows users to generate summary reports of this information, including, if known and as applicable, the trade name and/or established name of the product, dosage, route of administration, description of the adverse event, and the health outcome.  Adverse event report information should continue to be disclosed with a clear disclaimer about the limits of the information.

View Full Adverse Event Reports Section


Docket Management Process 
FDA does not now routinely post comments from people who identify themselves as “individual consumer” when they submit comments using www.regulations.gov

The Task Force proposes for public comment:

  1. FDA should change its current practice so that comments submitted at www.regulations.gov from people self-identified as individual consumers are posted on that website in the same manner as other comments.  In the Federal Register notice soliciting public comment, FDA should adequately inform commenters about the public disclosure of their comments on www.regulations.gov .

View Full Docket Management Process Section


Enforcement Priorities and Actions 
Each year, FDA’s Office of Regulatory Affairs (ORA) issues a workplan that provides estimated resource allocations and information regarding planned target activities, such as inspections.  This information is not disclosed due to a concern that it may provide regulated industry with information that may allow it to more easily avoid detection and circumvent the law.  FDA generally makes available on its web site press releases issued by the Department of Justice (DOJ) announcing when it files a case on FDA’s behalf, or the results of a case, but currently there is not a comprehensive list of the court actions pursued by FDA available to the public. 

The Task Force proposes for public comment:

  1. In the weekly FDA publication, FDA Enforcement Report, FDA should disclose when the U.S. Department of Justice files a case seeking enforcement action on FDA’s behalf in a court of law and the final determination of that case, if known. 
  2. FDA should post on its website all Agency Workplans (i.e., the annual Office of Regulatory Affairs Annual Field Workplan) that are older than five years, starting with the FY 2001 Workplan.

View Full Enforcement Priorities and Actions Section


Import Procedures 
Importers, or third parties working on behalf of importers, file information about products offered for import into the United States.  FDA conducts evaluations of those filers who submit information electronically to FDA to determine if they are submitting accurate and truthful data to FDA.  The outcome of the filer evaluation is not disclosed.

The Task Force proposes for public comment:

  1. FDA should disclose the outcome of the filer evaluation for importers or third parties working on behalf of importers.

View Full Import Procedures Section 


Inspections 

FDA conducts inspections of establishments that manufacture, process, pack, or hold FDA-regulated products before approving products and/or after products are on the market, to determine the establishment’s compliance with laws administered by FDA.  If objectionable conditions are observed, FDA provides the owner of the establishment with a document, called an FDA Form 483.  If no enforcement action is contemplated, or after enforcement action is concluded, FDA provides inspected establishments with a final inspection report, called an Establishment Inspection Report (EIR).  FDA proactively posts inspection reports (FDA Form 483s and EIRs) when a high level of public interest is anticipated.  The Agency also posts “frequently requested” inspection reports.

The Task Force proposes for public comment:

  1. FDA should disclose the name and address of the entity inspected, the date(s) of inspection, type(s) of FDA-regulated product involved, and the final inspectional classification—Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI)—for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.  The disclosure of this information should be timed so as not to interfere with planned enforcement actions.
  2. FDA should generate, and share with the public, information about the most common inspectional observations of objectionable conditions or practices that are made during inspections of FDA-regulated establishments and post that information online on a regular basis.

View Full Inspections Section


Product Applications (Including Investigational Applications) 
FDA generally does not disclose any information about the existence, status, or contents of an investigational application submitted to the Agency, until the product has been approved, licensed, or cleared.  Statutes and FDA regulations generally prohibit the release of information from or about an unapproved application. 

The Task Force proposes for public comment:

  1. FDA should disclose the existence and, when asked, confirm the existence or non-existence of investigational applications.  For investigational applications, the disclosure should include the name of the application sponsor, the date the application was received, the proposed indication(s) or intended use(s) of the product, and the proposed proper and/or trade name of the product, if available.
  2. FDA should disclose: (1) whether an investigational new drug application (IND) has been placed on hold, terminated, or withdrawn, whether an investigational device exemption (IDE) has been terminated or withdrawn, or whether an investigational exemption for a new animal drug has been terminated and (2) if an IND has previously been placed on hold, whether and when the hold is lifted.  A statement should be included that such actions may be taken for various reasons, only some of which relate to safety or effectiveness. 
  3. FDA should disclose the fact that an NDA, NADA, ANDA, ANADA, BLA, PMA, or 510(k) application or supplement was submitted (or resubmitted) to the Agency at the time the application is received by FDA.  The disclosure should include the name of the application sponsor, the date the application was received, the proposed indications or intended use of the product, and the proposed proper and/or trade name of the product, if available.
  4. FDA should disclose that an unapproved NDA, ANDA, NADA, ANADA, BLA, or PMA, or uncleared 510(k) has been withdrawn or, if FDA determines that the application was abandoned, abandoned by the sponsor.  If the drug, biological product, or device is associated with a significant safety concern, FDA should provide a brief description of the product, the use for which approval was sought or obtained, and the identified safety concern. 
  5. When an application for a designated orphan drug or a designated minor use/minor species animal drug has been withdrawn, terminated, or abandoned, FDA should disclose, if it determines, based on its review, that the application was not withdrawn, terminated, or abandoned for safety reasons and the product, if approved, could represent a significant therapeutic advance for a rare disease or for a minor animal species.  A disclaimer that provides that FDA’s expressed views about the product do not reflect whether a subsequent application involving the product will be accepted for filing or will be approved by FDA should accompany the disclosure of this information.
  6. FDA should disclose the fact that the Agency has issued a refuse-to-file or complete response letter in response to an original NDA, BLA, or an efficacy supplement for an NDA or BLA at the time the refuse-to-file or complete response letter is issued, and should, at the same time, disclose the refuse-to-file or complete response letter, which contains the reasons for issuing the letter. 
  7. FDA should disclose the fact that the Agency has issued a refuse to approve letter in response to a NADA, or a supplemental NADA to add a new species or indication, at the time the refuse to approve letter is issued, and should, at the same time, disclose the refuse to approve letter, which contains the reasons for issuing the letter.
  8. FDA should disclose the fact that the Agency has issued a “not approvable” letter in response to a PMA for a medical device and the fact that FDA has issued an “additional information (AI)” letter in response to a 510(k) submission, and should, at the same time, disclose the “not approvable” letter or “additional information (AI)” letter, which contains the reasons for issuing the letter. 
  9. FDA should disclose relevant summary safety and effectiveness information from an investigational application, or from a pending marketing application, if the Agency concludes that disclosure is in the interest of the public health, which includes when FDA believes it is necessary to correct misleading information about the product that is the subject of the application.
  10. FDA should convene a group of internal and external stakeholders to discuss the possible uses of non-summary safety and effectiveness data from product applications, the circumstances under which it would be appropriate for sponsors to disclose non-summary safety and effectiveness data from applications submitted to FDA, and if appropriate, the format and the method by which disclosure should occur.

View Full Product Applications (Including Investigational Applications) Section


Recalls 
When an FDA-regulated product is defective, potentially harmful, or mislabeled, recalling that product—removing it from the market or correcting the problem—is often the most effective means for protecting the public from products that violate the laws administered by FDA.  Generally, FDA does not have mandatory recall authority (i.e., authority to order a manufacturer and/or distributor to recall a product), except under limited circumstances, but a firm may initiate a recall at any time.  FDA issues a written notification that a recall is terminated to the recalling firm, but does not notify the public when a recall has been terminated. 

The Task Force proposes for public comment:

  1. When a system is set up that provides FDA with authority to require companies to submit certain information to the Agency when they initiate an action to recover or correct a product that is in the chain of distribution, FDA should disclose this information as soon as practicable after receiving this information from the firm.
  2. If FDA is aware of confusion in the marketplace about products that may be implicated in a food outbreak, and information gathered by industry or other sources may serve to alleviate that confusion, FDA should support efforts by industry and others to communicate information to the public about products that are not subject to the recall when sufficiently reliable information about products not connected with the recall exist, if FDA concludes that disclosure of this information is in the interest of public health. 
  3. If FDA determines that a recall is terminated, that information should be disclosed to the public.  A recall is considered terminated when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy and when it is reasonable to assume that the recalled product has been recovered, corrected, reconditioned, or destroyed. 

View Full Recalls Section


Warning and Untitled Letters 
FDA may issue either a warning letter or an untitled letter to individuals or firms notifying them of violations of the Federal Food, Drug, and Cosmetic Act (FDCA) to allow them an opportunity to voluntarily comply with the law.  The Agency posts warning letters on the FDA web site and if the Agency can determine that a firm has fully corrected violations raised in a warning letter, FDA will issue an official “close-out” notice that will also be posted the web site.  Some Centers proactively post untitled letters online.

The Task Force proposes for public comment:

  1. FDA should post untitled letters on the FDA website, and, if requested by the recipient of the letter, the response to the untitled letter, as appropriate.

View Full Warning and Untitled Letters Section