HHS Rule Agenda Includes 340B, FDA Regulations

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By Bronwyn Mixter

Nov. 23 — The latest HHS regulatory agenda includes several rules that would affect pharmaceutical companies, in areas such as drug discounts for safety-net providers and fixed-combination prescription drugs.

The fall 2015 agency rule list from the HHS was posted online Nov. 20 on the Office of Management and Budget's website. The agenda pushes back the expected release date for several Health and Human Services actions affecting drugmakers.

The HHS's Health Resources and Services Administration is planning a final rule and a proposed rule governing the 340B drug pricing program, which allows certain health-care providers (covered entities) to buy drugs at a discount. One rule (RIN 0906-AA89), required under the Affordable Care Act, would impose monetary sanctions (not to exceed $5,000 per instance) on drug manufacturers “who intentionally charge a covered entity a price above the ceiling price established under the procedures of the 340B Program and also define standards and methodology for the calculation of ceiling prices for purposes of the 340B Program,” the OMB website said.

This final rule is set for publication in May 2016, according to the agenda, and follows a June 2015 notice of proposed rulemaking on the subject (80 Fed. Reg. 34,583) (116 DER 116, 6/17/15). This rule has been delayed. In the spring 2015 regulatory agenda, the rule was set for publication in July.

The other 340B proposed rule on the agenda concerns an administrative dispute resolution process (RIN 0906-AA90). This rule also is required under the ACA and would implement “an enhancement to the 340B Program by establishing a required and binding administrative dispute resolution process to resolve claims raised by covered entities that they have been overcharged for drugs purchased under the 340B Program.” The OMB website noted that this administrative dispute resolution process also is available to drug manufacturers.

According to the OMB, May 2016 is the goal for publishing a proposal for the administrative dispute resolution, and it follows an advance notice of proposed rulemaking on Sept. 20, 2010 (79 Fed. Reg. 57,233). This rule also has been delayed as it was scheduled to be published in December 2015, according to the spring 2015 regulatory agenda.

HRSA also plans to issue a final guidance to address key policy issues raised by stakeholders for which the HHS doesn't have statutory rulemaking authority. The so-called omnibus guidance is scheduled to be published in September 2016. HRSA issued the proposed version of the omnibus guidance in August (See previous story, 08/28/15).

FDA Rules

In the area of Food and Drug Administration regulation, the agenda includes a proposal that would amend the agency's regulations on fixed-combination prescription and over-the-counter (OTC) drugs (RIN 0910-AF89).

The current regulations require, among other things, that the sponsor of a fixed-combination drug demonstrate that each of the components makes a contribution to the drug's claimed effects, the regulatory agenda said. The proposed rule would create a single set of regulations for prescription and OTC combination drugs, and codify existing policy on what kinds of studies are needed to show that the combination drug requirements are met. The proposed rule also would:

• apply these regulations to combinations of biological drug products and to drug-biological product combinations;
• clarify application of the FDA's requirements regarding fixed-dose combinations to certain natural source drugs and certain synthetic drugs;
• establish circumstances under which the agency might waive the combination requirements for a particular drug or biological product; and
• address the issue of co-packaging.


The proposed rule is set for publication in April 2016. In the spring regulatory agenda, the proposed rule was set for publication in August 2015.

Combo Products, Citizen Petitions

Also, in April 2016, the agency plans to issue a final rule (RIN 0910-AF82) that describes the postmarket safety reporting requirements for combination products (combinations of a drug, device and/or biological product). The rule would clarify that a combination product is subject to the reporting requirements associated with the type of marketing application under which the product is approved, licensed or cleared; and to certain additional, specified reporting requirements depending on the types of constituent parts (drug, device or biological product) of which it is comprised.

The FDA also anticipates issuing a final rule (RIN 0910-AG26) in March 2016 that would amend certain regulations relating to citizen petitions, petitions for stay of action and the submission of documents to the agency. The FDA said it is making these changes to implement certain provisions of the Food and Drug Administration Amendments Act (FDAAA) of 2007. Previously, the final rule was set for publication in January 2016.

Generic Drugs, Wholesaler Licensing

The agenda also includes a rule (RIN 0910-AF97) governing approval of generic drug applications. The proposed rule was published in February , and in April, the FDA extended the comment period on the proposed rule (Docket No. FDA-2011-N-0830) until June 8. The final rule is expected to be published in August 2016, according to the agenda.

The proposed rule implements portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which amended provisions of the Federal Food, Drug, and Cosmetic Act that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). ANDAs are used for generic drug approvals, while 505(b)(2) is a type of abbreviated pathway that allows the FDA to rely on data not developed by the applicant for approval of a new drug application.

By July 2016, the FDA plans to issue a final rule (RIN 0910-AG94) on procedures generic drug companies would use to change their labels to reflect new safety information in advance of the FDA's review of such a change. The proposed rule has been the subject of criticism from the generic drug industry and others, and the agency said in fall 2014 it was delaying the release of a final version until the end of September 2015. In the spring regulatory agenda, the final rule was scheduled to be issued in February 2016.

In June 2016, the FDA plans to issue a proposed rule (RIN 0910-AH11) to establish standards for state licensing of prescription drug wholesale distributors and third-party logistics providers. In the previous regulatory agenda, the rule was scheduled to be issued in December. The proposed rule also would establish a federal system for wholesale drug distributor and third-party logistics provider licensing for use in the absence of a state licensure requirement. The FDA is running behind on issuing this proposed rule. The Drug Supply Chain Security Act of 2013 (Pub. L. No. 113-54) requires the FDA to issue final regulations on these licensing requirements by Nov. 27, 2015.

Electronic Package Inserts

The FDA also plans in October 2016 to take final action on a proposed rule (RIN 0910-AG18) that would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper. These inserts contain prescribing information intended for health-care practitioners. In the previous agenda, the rule was set for publication in March 2016.

Additionally, in April 2016, the FDA anticipates issuing a final rule (RIN 0910-AA49) that will reorganize, consolidate, clarify and modify current regulations concerning who must register establishments and list human drugs, including certain biological drugs, and animal drugs. The rule contains information on when, how and where to register drug establishments and list drugs, and what information must be submitted. It also addresses national drug codes (NDCs). In the previous agenda, the rule was set for publication in October.

Drug Compounding

In January 2016, the FDA plans to issue a final rule (0910-AH08) to update and amend the list of drug products that may not be compounded by outsourcing facilities due to withdrawal or removal from the market because they have been found to be unsafe or ineffective. In the previous agenda, the rule was scheduled to be issued in September.

In March 2016, the FDA plans to issue a proposed rule (0910-AH29) that includes a list of bulk drug substances that may be used to compound drug products under Section 503A of the Federal Food, Drug, and Cosmetic Act. Section 503A governs traditional compounding pharmacies. The proposed rule will identify the criteria for evaluating bulk drug substances for inclusion on the list. It will propose an initial set of substances for inclusion on, and exclusion from, the list.

Other rules on tap from the FDA include a proposed rule on pediatric study plan requirements for new drug and biologics license applications (RIN 0910-AG93) and a proposed rule that would establish the format and content of reports to demonstrate substantial equivalence (RIN 0910-AG96).

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Nancy Simmons at nsimmons@bna.com

For More Information


The agenda can be accessed at http://tinyurl.com/oonsrlj.