Life Science Compliance Update

March 29, 2017

Chicago Releases Draft Rules on Industry Representative Licensure

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In a city where crime rates are sky-high and illegal drugs are easily picked up on the street, on November 16, 2016, the City of Chicago passed an ordinance that, effective July 1, 2017, requires pharmaceutical sales representatives to become licensed before they can promote prescription drugs to health care providers within city limits. 

Mayor Rahm Emanuel states that the new licensing requirement is part of a larger series of efforts by the city to combat heroin and opioid addiction. However, the law will impose significant new burdens on any pharmaceutical manufacturer with sales representatives who call on health care providers in Chicago.

The draft rules for this ordinance were released on March 17, 2017.

These recently-released draft rules provide additional detail regarding the licensure requirements as well as other associated education and disclosure requirements with which pharmaceutical representatives will be expected to comply beginning in July of this year.

To obtain their initial licensure as a pharmaceutical representative, applicants must complete an online course, for which proof of completion must be submitted. The cost of the initial license will run each representative $750. Then, to maintain the license, representatives must complete a minimum of five hours of continuing professional education every year thereafter. 

Approved providers for continuing professional education can be found on the city’s website. Making this burden even more onerous, continuing education provided by pharmaceutical manufacturers to their employees will not be accepted as fulfilling the requirement, unless the manufacturer previously applied for, and received, approval. A licensed representative who does not meet these continuing education requirements may face substantial penalties, including suspension or revocation of the license, inclusion in a public list of representatives whose licenses have been revoked, and/or a fine between $1,000 and $3,000 per day of violation.

In addition to the professional education requirement, pharmaceutical representatives will also be required to track and report certain sales information on an annual basis or upon request by the Commissioner of Public Health. This information must include: a list of the health care professionals who were contacted, the location and duration of each contact, the pharmaceuticals that were promoted, and whether product samples or any other compensation was offered in exchange for the contact.

For applicants who receive initial licensure, the time period for the data that must be collected and reported shall cover an 11-month period, starting on the first day of licensure and exactly ending one month before its expiration. For representatives with a renewed license, the data shall cover a 12-month period that will begin one month before the license renewal and will end one more before its expiration.  If the Commissioner of Public Health requests the information at any other time, the request will designate the time period the submission must cover, and it will be due within 30 days of the request.

A pharmaceutical representative who is found to have violated any provision of the Ordinance or these rules will be subject to suspension or revocation of licensure and/or a fine of $1,000 to $3,000 per day of violation. Inexplicably, once a license is revoked, it cannot be reinstated for a period of two years from the date of revocation.

These new requirements will place a significant burden on pharmaceutical manufacturers and their sales representatives who work in Chicago. Late last year, in an attempt to prevent the ordinance from going into effect, a coalition of sixteen pharmaceutical companies, along with organizations such as the Illinois Chamber of Commerce, the Illinois Manufacturer’s Association, the Epilepsy Foundation of Greater Chicago, and the Pharmaceutical Research and Manufacturers of America, wrote a letter to the City Council of Chicago expressing its concerns. The group noted, “[t]hese proposed reporting requirements are unnecessary and duplicating, creating an unnecessary tax on one of the most important sectors of our economy.”

The public is invited to submit any comments it may have on the proposed rules by April 2, 2017. readers are encouraged to send in comments, especially those local to the Chicago area to submit their comments about these regulations. The pharmaceutical industry is one of the most regulated industries in the country as it is.  The FDA requires reps to distribute REMS information on drugs that their company provides.  It is not clear how tracking the office visits and amount of time spent with healthcare providers by pharmaceutical reps is in the public interest.

February 10, 2017

FDA Finalizes Guidance on Assigning Non-Proprietary Names to Biologics and Biosimilars

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Recently, the Food and Drug Administration (FDA) finalized guidance detailing its approach to assigning non-proprietary names to biologics and biosimilars. The guidance, titled “Nonproprietary Naming of Biological Products,” finalizes an August 2015 draft of the same title. In the final guidance, the FDA says a biologic product’s nonproprietary name (“proper” name) will consist of two components: a “core name” and a distinguishing suffix (with no specific meaning) composed of four letters. The FDA, however, did not finalize an approach to the suffix format for interchangeable products.

Scope

The FDA intends to apply the naming convention to both newly licensed and previously licensed biological products. The FDA is also continuing to consider the process for implementation of the naming convention for previously licensed products but, for right now, intends to assign distinguishing suffixes to a limited group of these products and will accept submissions of prior approval labeling supplements that include proposed suffixes.

Core Name

FDA says the core name will be the name designated by the USAN Council for the originator biologic product, and that any related biological product, biosimilar product, or interchangeable product will have the same core name. The FDA notes in the guidance that “use of a shared core name will indicate a relationship among products.”

Distinguishing Suffix

For the second component of a product’s proper name, the FDA says “a distinguishing suffix that is devoid of meaning and composed of four lowercase letters will be attached with a hyphen to the core name of each originator biological product, related biological product, or biosimilar product.” The agency notes that its choice of using a suffix rather than a prefix will help products with the same core name being grouped “together in electronic databases to help health care providers locate and identify these products.”

Inadvertent Substitution

The finalized naming approach “should help prevent inadvertent substitution” which can lead to “unintended alternating or switching of biological products that are not determined by FDA to be interchangeable with each other,” the agency says. The FDA notes the distinguishing suffix should clear up potential confusion when related biological products are licensed for different indications, different routes of administration, or fewer than all indications for which the reference product is licensed.

The FDA also says the unique suffix should also prevent confusion among health care providers who, “based on their experience with small-molecule drugs and generic versions of those drugs, may incorrectly assume that FDA has determined biological products with the same proper name to be interchangeable.”

Interchangeability

In the guidance, the FDA says that it is continuing to consider the appropriate suffix format for interchangeable products. The FDA says it intends to apply a naming convention to interchangeable products that will feature a core name and a suffix included in the proper name; however, FDA is continuing to consider the appropriate format of the suffix for these products.

In addition, FDA requests that biologic and biosimilar applicants and application holders propose a suffix composed of four lowercase letters for use as the suffix included in the proper name.

January 26, 2017

FDA Releases Draft Guidance on Manufacturer Communications with Payors, Formulary Committees, and Similar Entities

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In mid-January 2017, the United States Food and Drug Administration (FDA) released a guidance document, entitled Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities – Questions and Answers,” explaining FDA’s current thinking regarding communications by medical product manufacturers, packers and distributors of health care economic information (HCEI) about approved prescription drugs to payors and formulary committees.  The draft guidance also provides answers to common questions about dissemination of information by firms regarding investigational drugs and devices to payors before FDA clearance or approval of those products.

HCEI is defined in the document as “any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or compromising the analysis) that identifies, measures, or describes the economic consequences of the represented health outcomes, of the use of a drug.” HCEI pertains to the economic consequences related to the clinical outcomes of treating a disease (or specific aspect of a disease) or of preventing or diagnosing a disease. According to the FDA, HCEI may be presented in a variety of ways that can include, but are not limited to, an evidence dossier, a reprint of a publication from a peer-reviewed journal, a software package comprising a model with user manual, or a budget-impact model.

HCEI is not to be considered false or misleading if, among other things, it “relates to an [approved] indication.” To be considered related to an approved indication, HCEI analyses should relate to the disease or condition, manifestation of the disease or condition, or symptoms associated with the disease or condition in the patient population for which the drug is indicated in the FDA-approved labeling. Pages six through eight of the guidance have a table of HCEI analyses that relate to the approved indication.

In the guidance document, FDA defines “payors” as including payors, formulary committees, or other similar entities responsible for making drug selection, formulary management and/or coverage and reimbursement decisions regarding drugs and/or devices for health care organizations, including integrated health care delivery networks, hospitals and hospital systems.  In the guidance, FDA notes that if a firm disseminates HCEI about an approved drug consistent with the guidance, when finalized, FDA does not intent to consider such information false or misleading or as providing evidence of a new intended use.

In an accompanying Federal Register notice, FDA announced that it is reopening the comment period related to a previous public hearing concerning manufacturer communications regarding unapproved uses of approved or cleared medical products. This comment period will be reopened for 90 days, beginning January 19, 2017.

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