Drug Importation Is A High-Profile Addition To US FDA’s Regulatory Agenda

Agency is targeting January 2020 for release of controversial proposed rule to allow importation of certain types of prescription drugs from Canada; although most Rx drug-related proposed and final rules on the Fall 2019 regulatory agenda are making repeat appearances, a final rule on electronic distribution of prescribing information has fallen off the list.

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US FDA provides a peek at the proposed and final regs it anticipates releasing in the coming months.

Drug importation is a high-profile addition to the US Food and Drug Administration’s semi-annual regulatory agenda released on 20 November.

The agency is targeting January 2020 for release of what will surely be a controversial proposed rule to allow importation of certain types of prescription drugs from Canada.

The rule is expected to create a process for third parties to obtain FDA certification to permit imports under Section 804 of the Food, Drug and Cosmetic Act. (Also see "Canadian Importation Option May Be Hindered By Product, Savings Restrictions" - Pink Sheet, 31 Jul, 2019.)

Section 804, which would allow wholesale parallel trade in drugs as a cost-containment measure, has never been implemented because the Department of Health and Human Services has never certified that such imports could be done safely and would lower costs.

However, it appears all that is about to change as the Trump Administration looks to take action aimed at combating high drug prices. (Also see "The FDA Commissioner Shuffle And Canadian Rx Imports" - Pink Sheet, 5 Nov, 2019.)

“Benefits from the proposed rule would be in the form of cost savings to consumers, which depend on the scope and scale of activities authorized under these regulations.” – FDA regulatory agenda

“This proposed rule, if finalized, would allow importation of certain drugs under certain circumstances. Pharmacists and wholesalers would be allowed to import prescription drugs from Canada into the US if they meet conditions designed to ensure that the importation poses no additional risk to safety and will achieve cost savings,” the regulatory agenda states.

The Trump Administration acknowledges the proposed rule would create costs associated with the conditions required to ensure implementation poses no additional safety risks and generates costs savings, “including costs to government associated with the implementation and monitoring of any activities authorized under these regulations.”

However, “benefits from the proposed rule would be in the form of cost savings to consumers, which depend on the scope and scale of activities authorized under these regulations.”

‘The Tome’ 2.0?

Almost all the other proposed and final rules listed on the Fall 2019 regulatory agenda are making a repeat appearance, although in some cases the status of expected action has changed. (See table on expected Rx drug and biologic regulatory actions at end of story.)

In the latter category is a plan for a new proposed rule on postmarketing safety reporting requirements for human drug and biological products.

The FDA originally attempted to revise its postmarketing safety reporting regulations in a massive 2003 proposal known as “the tome” that also covered premarketing safety reporting requirements. The premarketing safety requirements were eventually finalized in a separate rule published in September 2010. (Also see "FDA IND Safety Reporting Rule: New Types Of Data Must Be Submitted" - Pink Sheet, 4 Oct, 2010.)

The postmarketing safety reporting requirements appear to have been extensively revamped. The agency expects to release a notice of proposed rulemaking in June 2020. In contrast, the Spring 2019 regulatory agenda listed plans for a final rule.

Right-To-Try Rule Coming Soon?

Among the listed regulatory actions that appear imminent are a proposed rule establishing requirements for the deadline and contents of annual summary submissions by manufacturers who make drugs available to eligible patients under the federal Right To Try Act. The proposed rule is targeted for release this month.

In addition, a number of proposed and final rules are aimed at harmonizing FDA regulations with statutory changes.

Among these are a proposed rule to amend patent term restoration regulations to identify the effective date of approval for drugs subject to controlled substance scheduling, and to define when the 60-day review period begins and explain how approvals after 4:30 p.m. fit in this definition for purposes of filing an application for a patent term extension.

These changes are aimed at aligning agency regulations with the Improving Regulatory Transparency for New Medical Therapies Act of 2015 and the America Invents Act of 2011, Kurt Karst, a director at Hyman, Phelps and McNamara in Washington, DC, told the Pink Sheet. (Also see "Patent Reform: Senate May Amend Two Provisions In House Bill" - Pink Sheet, 5 Sep, 2011.)

One notable proposal that has dropped off the most recent regulatory agenda is a rule that would have required electronic package inserts for drugs and biologics in lieu of paper. (Also see "Generic Labeling Rule Dies In Latest Reg Agenda, But Electronic Labeling Is Reborn" - Pink Sheet, 14 Dec, 2017.) A proposed rule issued in December 2014 faced opposition from pharmacists and members of Congress, leading lawmakers to bar the agency from using funds to implement the regulation "unless and until" a federal law allowing it is enacted. (Also see "US FDA Wins Big In Shutdown-Averting Approps Bill" - Pink Sheet, 14 Feb, 2019.)

The electronic distribution rule was listed as a “long-term action” in the Spring 2019 regulatory agenda.

US FDA’s Fall 2019 Regulatory Agenda

Title	Description	Status
Proposed Rule Stage
Postmarketing Safety Reporting Requirements for Human Drug and Biological Products	Amendment to postmarketing safety reporting regulations to better align FDA requirements with International Council on Harmonisation guidelines and to update reporting requirements in light of current pharmacovigilance practice and safety information sources.	Reproposing notice of proposed rulemaking expected June 2020
Pediatric Study Plan Requirements for New Drug and Biologics License Applications	Requirements for the content of initial pediatric study plans required under the Pediatric Research Equity Act.	Notice of proposed rulemaking expected September 2020
National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers	Establish standards for state licensing of Rx drug wholesale distributors and third-party logistics providers and establish a federal licensing system for use in the absence of a state program.	Notice of proposed rulemaking expected January 2020
Post-approval Changes to Approved Applications	Update the existing regulations governing supplements and other changes to approved NDAs, ANDAs and BLAs, and certain post-approval reports.	Notice of proposed rulemaking expected September 2020
Certain Requirements Regarding Prescription Drug Marketing (203 Amendment)	Amending regulations at 21 CFR 203 to remove provisions no longer in effect and incorporate conforming changes following enactment of the Drug Supply Chain Security Act.	Notice of proposed rulemaking expected January 2020
Medication Guide; Patient Medication Information	Amend medication guide regulations to require a new form of patient labeling, Patient Medication Information, for Rx drug products used on an outpatient basis.	Notice of proposed rulemaking expected June 2020
Amendments Regarding the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the FD&C Act	Add bulk drug substances to the list of substances that may be used to compound drug products that qualify for the exemptions in Section 503A.	Notice of proposed rulemaking September 2019; comment period ends 4 December 2019
Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards	Harmonize certain provisions of regulations on human subject protection and institutional review boards with the recently revised "Federal Policy for the Protection of Human Subjects” (the revised Common Rule).	Notice of proposed rulemaking expected November 2019
Institutional Review Boards; Cooperative Research	Replace current requirements for cooperative research such that any institution located in the US participating in multisite cooperative research would need to rely on approval by a single IRB for that portion of the research that is conducted in the US, with some exceptions; establish an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution.	Notice of proposed rulemaking expected November 2019
Responsibilities for the Initiation and Conduct of Clinical Investigations	Updates IND regulations to better define and clarify the roles and responsibilities of the various persons engaged in the initiation, conduct and oversight of clinical investigations subject to IND requirements.	Notice of proposed rulemaking expected September 2020
Biologics Regulation Modernization	Clarify existing requirements and procedures related to BLAs and promote the goals associated with implementation of the abbreviated licensure pathway created by the Biologics Price Competition and Innovation Act.	Notice of proposed rulemaking expected December 2019
Amendments to Patent Term Restoration	Amendments to identify the effective date of approval for scheduled drugs, to define when the beginning of the 60-day review period occurs, including the term “business day," and to explain how approvals after 4:30 pm fit in this definition.	Notice of proposed rulemaking expected February 2020
Amendment to Records and Reports Concerning Adverse Drug Experiences on Marketed Prescription Drugs for Human Use Without Approved New Drug Applications	Amendment to clarify when adverse event reports should be submitted for marketed Rx drugs not subject of an approved NDA or ANDA.	Notice of proposed rulemaking expected May 2020
Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the FD&C Act	Establish the criteria by which drug products and categories of drug products will be evaluated for inclusion on the Difficult to Compound List for section 503A and the Difficult to Compound List for section 503B, and to include certain categories of drug products on these lists.	Notice of proposed rulemaking expected February 2020
Annual Summary Reporting Requirements Under the Right to Try Act	Establish requirements for the deadline and contents of submission of annual summaries by sponsors and manufacturers who provide an eligible investigational drug for use under the Right to Try Act.	Notice of proposed rulemaking November 2019
Human Tissue Intended For Transplantation	Revoke outdated and obsolete regulations under 21 CFR part 1270 applicable to certain human tissues recovered prior to May 2005.	Notice of proposed rulemaking expected June 2020
Importation of Prescription Drugs	Allow pharmacists and wholesalers to import prescription drugs from Canada if they meet conditions designed to ensure that the importation poses no additional risk to safety and will achieve cost savings	Notice of proposed rulemaking expected January 2020
Final Rule Stage
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, Neutral Manner	Require that the major statement in DTC television and radio ads relating to the side effects and contraindications of an advertised prescription drug be presented in a clear, conspicuous, and neutral manner and establish appropriate standards.	Final rule expected June 2020
Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation	Repeal a regulation that requires an approved NDA or ANDA for any drug product that is sterilized by irradiation.	Final rule expected December 2019
Biologics License Applications and Master Files	Permit the continued use of DMFs for NDAs subject to the BPCIA transition provisions.	Final rule expected February 2020
IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations	Permit an IRB to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent under limited conditions for certain minimal risk clinical investigations.	Final rule expected September 2020
Definition of the Term "Biological Product"	Amend regulation that defines biological product to conform to the statutory definition adopted in the BPCIA.	Final rule expected January 2020
Updating Public Information Regulations	Bring regulations in line with statutory amendments to the Freedom of Information Act, update cross references to other statutes and parts of the agency’s regulations, and clarify certain provisions with minor editorial updates; update current regulations to reflect changes to the organization, to make the FOIA process easier for the public to navigate, and to make certain provisions clearer.	Final rule expected December 2019
Revision of Product Jurisdiction Regulations	Amend regulation on classifying medical products as drugs, devices, biological products or combination products and on center assignment and regulation of combination products.	Final rule expected March 2020
Revocation of the Test for Mycoplasma	Remove the specified test for presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in-vitro living cell cultures.	Final rule expected April 2020
Long-Term Actions
Current Good Manufacturing Practice for Outsourcing Facilities	Minimum current good manufacturing practice requirements for human drug products compounded by an outsourcing facility.	Notice of proposed rulemaking expected December 2020