Life Science Compliance Update

October 06, 2017

FDA Releases Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity

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The FDA announced a draft guidance for industry titled “Statistical Approaches to Evaluate Analytical Similarity”. The draft guidance offers advice to biosimilar sponsors on the evaluation of analytical similarity of a biosimilar to its reference product. FDA says this type of evaluation is performed as part of the biosimilar approval process to support a demonstration that the proposed biosimilar is highly similar to a reference product.

The draft guidance describes “the type of information a sponsor of a proposed biosimilar product should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan for the proposed biosimilar, and the statistical approaches recommended for evaluating analytical similarity.”

The draft guidance released is part of a series of guidance documents that FDA is developing related to the biosimilar approval process. Comments on the draft guidance are due to FDA within 60 days; on or around November 22, 2017. All submissions received must include the Docket No. FDA-2017-D-5525 for “Statistical Approaches to Evaluate Analytical Similarity; Draft Guidance for Industry; Availability.”

Guidance Specifics

According to the FDA, the objective of this guidance is to assist sponsors in demonstrating, through an evaluation of the analytical similarity of the proposed biosimilar and reference product, that the proposed biosimilar and reference product are highly similar to support licensure under section 351(k) of the PHS Act. In general, an analytical similarity assessment involves a comparison of structural/physicochemical and functional attributes using multiple lots of the proposed biosimilar product and the reference product.

To address the challenges of conducting appropriate statistical analyses in the evaluation of analytical similarity, FDA recommends using a risk-based approach. This approach to the evaluation of analytical similarity consists of several steps:

  • The first step is a determination of the quality attributes that characterize the reference product in terms of its structural/physicochemical and functional properties.
  • In the second step, these quality attributes are then ranked according to their risk of potential clinical impact.
  • Third, these attributes/assays are evaluated according to one of three tiers of statistical approaches based on a consideration of risk ranking as well as other factors. However, some attributes may be important but not amenable to quantitative evaluation.

FDA recommends that the analytical similarity evaluation begin with an understanding of the structural/physicochemical and functional attributes of the reference product. Based on information obtained about these attributes during development of the proposed biosimilar, the sponsor should develop an analytical similarity assessment plan. A key component of this plan is the description of lots available for similarity testing.

In general, principles for evaluating analytical similarity should be assessed by using appropriate statistic methods to evaluate the analytical data. Methods of varying statistical rigor should be applied depending on the risk ranking of the quality attributes. Sponsors should develop an analytical similarity assessment plan that includes their proposed statistical approach to evaluation and then should discuss this approach with the FDA as early in the development program as feasible.

The final analytical similarity report, which should include the analytical similarity assessment plan, should be included when a 351(k) biologics license application is submitted. The development of the analytical similarity assessment plan is the topic of the first subsection of the guidance, followed by a discussion of FDA’s current thinking on the statistical methods to be applied for evaluation.

June 23, 2017

Chicago’s Attempt to Regulate Drug Reps - A Real Public Health Initiative or Simple Revenue Generator?

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Lately pharmaceutical marketing has been under increasing attack at both state and federal governmental levels. Now Chicago has joined D.C. in the attempt to regulate pharmaceutical representatives. Billed by Chicago Mayor Rahm Emanuel as a measure to curb opioid addiction, the actual purpose seems less clear. What is clear is that the ordinance will induce additional costs and complexities for pharmaceutical compliance officers charged with overseeing sales activities.

The origins of the Chicago ordinance date back to October 2016. The city faced with increasing crime and overdose rates tied to illegal drugs needed to do something. As a result, Mayor Rahm Emmanuel announced new initiatives to combat heroin addiction in Cook County based on recommendations developed by a Task Force. Part of those initiatives was increasing the regulation of pharmaceutical representatives working within Chicago.

It is interesting to note that nowhere in the recommendations of the Task Force was there a call for licensing pharmaceutical representatives. However, the Mayor in his press releases stated that the new licensing requirement is part of a larger series of efforts by the city to combat heroin and opioid addiction. The Illinois Attorney General echoed this sentiment. “I support the City’s efforts to license pharmaceutical sales representatives to curb the abusive overprescribing of opioid painkillers that feed our country’s heroin epidemic,” said Illinois Attorney General Lisa Madigan. “My office has investigated misconduct of pharmaceutical sales representatives and recently filed a lawsuit against the maker of a powerful opioid for directing its sales reps to promote prescriptions for inappropriate uses that can be addictive and deadly.”

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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.

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