Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) gives FDA new authorities to help ensure the safety, effectiveness and quality of drugs in the United States. The 18 sections of Title VII are summarized below.
- Sec. 701-702, Registration of Domestic and Foreign Drug Establishments
- Sec. 703, Identification of Drug Excipient Information with Product Listing
- Sec. 704, Electronic System for Registration and Listing
- Sec. 705, Risk-based Inspection Frequency
- Sec. 706, Records for Inspection
- Sec. 707, Prohibition Against Delaying, Denying, Limiting or Refusing Inspection
- Sec. 708, Destruction of Adulterated, Misbranded or Counterfeit Drugs Offered for Import
- Sec. 709, Administrative Detention
- Sec. 710, Exchange of Information
- Sec. 711, Enhancing the Safety and Quality of the Drug Supply
- Sec. 712, Recognition of Foreign Government Inspections
- Sec. 713, Standards for Admission of Imported Drugs
- Sec. 714, Registration of Commercial Importers
- Sec. 715, Notification
- Sec. 716, Protection against Intentional Adulteration
- Sec. 717, Penalties for Counterfeiting Drugs
- Sec. 718, Extraterritorial Jurisdiction
Section 701 amends current law relating to registration of domestic drug establishments to require facilities to register between October 1 and December 31 of each year and to provide additional information including a unique facility identifier (UFI) for each establishment and a point-of-contact email address. Section 702 imposes the same registration requirements on foreign facilities. On November 5, 2014, FDA issued a final guidance specifying the UFI.
This section requires manufacturers who register to include, as part of a drug listing, the name, address and unique facility identifiers (UFIs) of associated excipient manufacturers. Implementing Section 703 is expected to be a longer-term effort.
This section requires FDA to maintain an accurate electronic registration and listing database that is searchable and uses the UFI to link to other relevant FDA databases in order to identify and inform risk-based inspections.
This section requires FDA to replace the previous two-year drug inspectional frequency requirement with a risk-based inspection schedule for domestic and foreign drug facilities. Inspection criteria include the establishment’s compliance history and the inherent risk of the drug being manufactured. FDA is developing risk-based methodologies for inspections to reflect the statutory criteria and is working to establish common risk principles across the various Centers. By February 1 of each year, FDA will publish reports on its website that include the number and type of registered establishments inspected and the percentage of the FDA budget used to fund such inspections.
This section allows FDA to obtain certain records and other information from a drug manufacturer in lieu of or in advance of an inspection. The request for information must include a description of the information requested, and the information shall be provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner. In one program, FDA's Office of Regulatory Affairs (ORA) has requested and reviewed records in advance of a number of already planned inspections conducted by ORA, and is using the results to inform its Agency-wide policy and process to ensure that similar requests are carefully implemented. The updated Agency-wide procedures describe use of this authority.
In a second program, FDA’s Office of Pharmaceutical Quality is leading the development of policy on applying this section to its Quality Metrics program in order to: (1) inform the risk-based inspection frequency model in advance of inspections (refer to Sec. 510(h) of the FD&C Act), and (2) identify signals for early detection of potential public health incidents (e.g., interruption in drug supply).
This section deems adulterated any drug that is manufactured in an establishment that delays, limits, denies or refuses to permit entry or inspection. On July 12, 2013, FDA issued a draft guidance, and on October 22, 2014, FDA issued final guidance with examples of the types of conduct that FDA considers to be in violation of Section 501(j) of the FD&C Act. This guidance also specified that under certain circumstances delaying, denying, limiting or refusing a request for records in advance or in lieu of an inspection under Section 706 may also result in a manufacturer’s drugs being adulterated under the FD&C Act.
This section provides authority to FDA to destroy, without the opportunity for export, drugs refused admission that are valued at $2,500 or less. On May 6, 2014, FDA issued a proposed rule, and on September 15, 2015, FDA issued the final rule regarding administrative destruction of imported drugs refused admission to the U.S. The rule provides the provides the owner or consignee of the drug with notice and an opportunity to provide testimony prior to the destruction. Administrative destruction will help deter the importation of violative drugs and lessen FDA’s expenditure of resources on refused drugs.
This section extends to drugs under FDA’s current statutory authority to administratively detain, for a reasonable period of time, devices and tobacco products that an FDA investigator has reason to believe is adulterated or misbranded. FDA is required to issue regulations implementing this section no later than July 9, 2014. On July 12, 2013, FDA issued a proposed rule to implement this section, and on May 29, 2014, issued the final rule. The regulation mirrors the regulation for administrative detention of devices, as the statutory administrative detention authority is the same for both drugs and devices.
This section allows FDA to enter into written agreements to furnish certain trade secret information to foreign governments that have the authority and demonstrated ability to protect trade secret information, as certified by the Commissioner. Information concerning an inspection may only be shared if the foreign government already has authority to obtain such information, and if the written agreement limits the information’s use to civil regulatory purposes. This section also grants FDA authority to protect from disclosure information obtained from a foreign government agency if the information concerns the inspection of a facility, is part of an investigation, alerts the United States to the potential need for an investigation, or concerns a drug that has a reasonable probability of causing serious adverse health consequences or death, and such information is provided voluntarily on the condition that it not be released and is covered by a written agreement. FDA is currently exploring the authority granted to it under Section 710 to determine how it can be used to advance FDA’s existing activities and initiatives to exchange information with its foreign counterparts.
This section clarifies that current good manufacturing practice (CGMP) includes having oversight and control over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of ingredients, raw materials used in manufacturing, and finished drug products. While this provision is self-executing, FDA is revising existing CGMP regulations, consistent with this provision, to ensure oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of components used in manufacturing finished pharmaceuticals. This revision will update and harmonize requirements and improve detection of and response to emerging product safety and quality signals.
This section allows FDA to enter into written agreements with foreign governments to recognize the inspection of foreign drug establishments for the purpose of facilitating FDA’s risk-based inspection schedule. The results of such inspections also may be used as evidence of compliance with standards for admission established under Section 713 and for any other purposes FDA deems appropriate. Such agreements may be entered into only with foreign governments that FDA has determined have the capability of conducting inspections that meet FD&C Act requirements, and FDA must perform reviews and audits of the foreign agency to ensure that this is the case. FDA is currently determining how this authority can be used to advance existing efforts in this area and further FDA’s goal of relying on foreign government inspections.
This section allows FDA to require electronic submission of information by a drug importer demonstrating compliance with the FD&C Act as a condition of granting entry of a drug into the United States. It also allows FDA to take into account differing levels of risk among importers and imports, and provide for expedited clearance for importers that participate in voluntary partnership programs for highly compliant companies. On July 12, 2013, FDA held a public meeting to obtain additional input from stakeholders on the information that importers should be required to provide under this section, and how FDA should approach establishing voluntary compliance certification programs. Input received at the meeting and written comments submitted by stakeholders will be considered by FDA in developing the regulations, which must be issued by January 9, 2014.
This section requires commercial importers to register with FDA and submit a UFI. It also requires FDA, in consultation with the Secretary of Homeland Security acting through Customs and Border Protection, to issue regulations to establish good importer practices (GIPs) that specify the measures an importer shall take to ensure that imported drugs comply with U.S. law. The section specifies that if importers do not comply with GIPs, their registration will be discontinued. On July 12, 2013, FDA held a public meeting to obtain additional input from stakeholders on the types of entities that should be required to register under this section and the types of measures that should be required as part of GIPs. Input received at the meeting and written comments submitted by stakeholders will be considered by FDA in developing the regulations, which must be issued by July 9, 2015.
This section allows FDA to require, by regulation or guidance, that “regulated persons” notify the Agency of knowledge that the use of their drug in the United States may result in serious injury or death, or that a significant loss or known theft of their drug has occurred, or that their drug has been or is being counterfeited, and has been or could reasonably be expected to be brought into the U.S. market. The section defines “regulated persons” as any person required to register, wholesale drug distributors, or any other distributors other than retail drug sellers. FDA is developing a draft guidance that specify how manufacturers are to report these events.
Under this section, a person who knowingly and intentionally adulterates a drug and creates a reasonable probability that the drug will cause serious adverse health consequences or death is subject to imprisonment for not more than 20 years or a fine of not more than $1 million, or both. Based on recommendations from FDA, the Sentencing Commission adopted a proposed amendment to the Sentencing Guidelines that added a reference to the new statutory adulteration provision in the appropriate section of the Guidelines. The proposed amendment was submitted to Congress on May 1, 2013 and will become effective on November 1, 2013 unless modified or disapproved by Congress.
This section amends the criminal statute on counterfeit trafficking to specifically include counterfeit drugs, directs the Attorney General to give increased priority to prosecution of cases involving counterfeit drugs, and directs the U.S. Sentencing Commission to review and consider amending the Sentencing Guidelines to increase the penalties for counterfeit drug offenses. Based on recommendations from FDA, the Sentencing Commission adopted a proposed amendment to the Sentencing Guidelines that revised the section on penalties for counterfeit trafficking to increase by two levels the penalties applicable to offenses involving counterfeit drugs. The proposed amendment was submitted to Congress on May 1, 2013 and will become effective on November 1, 2013 unless modified or disapproved by Congress.
This section makes extraterritorial violations of the FD&C Act subject to enforcement in the United States if the article related to the violation was intended for import into the United States or an act in furtherance of the violation was committed in the United States. This section is self-executing, and requires no further action by FDA to implement.