Tag: regulations

  • A winning approach

    A winning approach

    Jason Rock image and biography

    Jason Rock is the chief technology officer and co-founder of GlobalSubmit.

     

    Rock has been integral in the FDA’s efforts to harmonize regulatory submission standards for the tobacco industry, as he was when the FDA first implemented similar standards for life sciences.

     

    He served as the project lead for the first-ever MRTP application accepted for review by the CTP and the first-ever approved PMTA.

     

    During the April 9–10, 2015, Tobacco Products Scientific Advisory Committee (TPSAC) meeting to discuss MRTP applications submitted by Swedish Match, Rock was the only non-FDA, non-tobacco industry participant to address the audience.

     

    Best practices for filing FDA tobacco product applications

    By Jason Rock

    The final deeming regulation extending the U.S. Food and Drug Administration’s (FDA) authority to additional products has, to put it mildly, captured the attention of the entire tobacco industry. A predicate—or “grandfather”—date of Feb. 15, 2007, will force the majority, if not all, of e-cigarette or electronic nicotine-delivery system manufacturers into the premarket tobacco product application (PMTA) pathway—the costliest and most complex avenue from a regulatory standpoint.

    In this article, I’ll give you an idea of what to expect when filing a large application to the FDA and provide general guidelines for formulating a successful approach.

    Similarities between pharma and tobacco

    A few years ago, I read an account from a major tobacco company executive predicting that tobacco companies would one day be regarded in the same vein as pharmaceuticals. The comparison is especially apt when considering the size and content of applications. Typically, a large New Drug Application (NDA) submitted to the FDA contains 20–25 studies and ranges anywhere from 100,000–300,000 pages. There are always exceptions, and I’ve seen applications with as few as five studies while others have broken the 100-study barrier.

    In all likelihood, PMTAs are comparable in scope, if not equivalent, to these large marketing applications. Modified-risk tobacco products (MRTPs) are much larger, as they require the submission of case report forms. Swedish Match, the first company to receive marketing authorization from the FDA under the PMTA pathway, submitted a 130,000-page MRTP application for eight products.

    Timing and project management

    If you’re committed to the PMTA pathway, the date marked on your calendar is Aug. 8, 2018. A missed filing deadline could trigger FDA enforcement action for your products currently on the market. Work on large pharmaceutical applications typically precedes the filing date by at least 12 months. It’s not unusual for applicants to begin work 18–24 months prior to the filing deadline set for an NDA.

    A winning timing strategy for PMTAs is to start early and set an internal submission target for six months prior to the statutory deadline (Feb. 8, 2018). The natural instinct is to start the submission process once your summary documents are in progress. Don’t wait! Start early to lower your risk. Any studies already completed should be published as soon as possible, whereas other parts of the application can be completed on a rolling basis. Plan for late document delivery and work ahead. We believe it’s better to have 20 percent of the documents 100 percent complete versus 100 percent of the documents 20 percent complete.

    In terms of project management, you’ll want to appoint an internal resource to manage the document production process or find an expert with experience. A custom tracking tool is the most plausible solution for tracking the delivery date and submission readiness for each document.

    You’ll want to schedule a pre-submission meeting with the FDA to review your strategy. The probability of project success goes up if you can achieve agency buy-in up front.

    Submission publishing standards

    In preparing electronic applications for drug products, pharmaceutical companies have to adhere to internationally harmonized standards for documents and folder structures or face technical rejection. These standards have been in place for over a decade. And while regulatory requirements around PDF versions, bookmarks and hyperlinks, fonts, and headings and hierarchy might sound unduly burdensome, the formatting standards are integral to streamlined document review and timely approval.

    Without the luxury of documented standards as are in place for pharmaceutical companies, tobacco applicants should strive to meet as many existing standards as possible. The men and women who will ultimately review your tobacco applications are descendants of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. The reviewers are familiar with pharmaceutical standards and prefer tobacco submissions to resemble what they are used to receiving.

    Your strategy should center on setting up a pre-submission meeting with the FDA Center for Tobacco Products  and proposing use of existing standards such as CDISC (Clinical Data Interchange Standards Consortium ) or CDISC-like datasets for clinical and nonclinical study data, International Conference on Harmonization E3 guidelines for clinical study reports, pre-eCTD PDF publishing specifications, and best practices for laboratory testing and manufacturing.

    Cost

    How much does it cost to prepare a PMTA?

    The answer depends on who you ask. In the final deeming regulation, the FDA estimated an effort of more than 1,700 hours to prepare a PMTA, which adds up to roughly $1 million per product. Independent tobacco industry figures project a high-end cost of up to $10 million per PMTA, if not higher.

    Submission publishing, project management and quality review of documents fit into the administrative portion of the estimate. As is true in the pharmaceutical industry, these activities are the least expensive part of a very expensive process. Standard rates for submission publishing and related activities are set per page. For a quick ballpark estimation, you can use a $5 per page rate inclusive of publishing, management and other tasks.

    Learn from experience

    Prior to the successful MRTP and PMTA submission filed by Swedish Match, a number of applicants were rejected by the FDA for failure to adhere to the aforementioned standards and failure to adequately articulate a submission strategy.

    In the early preparatory stages of its filing, Swedish Match was challenged about the mechanics of filing an MRTP application. In the end, three key discoveries emerged: (1) the true scope of the project, (2) the FDA’s expectations for document formatting and (3) the role of correspondence with the FDA CTP during the project.

    Successfully filing a PMTA requires drawing on the considerable experience of the pharmaceutical industry, starting the process early and securing the proper expert resources, adhering to existing and agreed upon standards, and following the lead of others who have achieved the desired outcomes.

     

     

     

     

     

     

     

     

  • Cigar makers hope to snuff out FDA efforts

    Cigar makers are trying to snuff out an effort by the Food and Drug  Administration to regulate their products for the first time.

    The FDA said in its regulatory agenda for the year that it would propose rules in April to expand federal oversight of tobacco products under the Family Smoking Prevention and Tobacco Control Act. The news was welcomed by tobacco giants, such as Altria, that want all tobacco products to be brought under the same regulations, according to a Washington, D.C. regulation blog The Hill.

    Sellers and makers of premium cigars — often hand-rolled, slow-burning and made with aged tobacco leaves — say the FDA is overreaching, and are hiring lobbyists to fight back.

    Glynn Loope, the executive director of Cigar Rights of America, said the  FDA’s move is “a classic case of going beyond congressional intent.”

    “When Congress passed the original Tobacco Control Act, it was really to address two primary points: youth access to tobacco and chemical addition. Premium cigars don’t meet that criteria,” Loope  said.

    Another trade group for cigar retailers and manufacturers agreed that the FDA  is distorting the law.
    “It’s our belief that the act was to prevent youth from smoking and curtail the health effects for youth,” said Bill Spann, CEO of the International Premium Cigar & Pipe Retailers Association.

    Spann said FDA meddling could have a devastating impact on cigar shops. The group has warned that regulators could ban walk-in humidors and seasonal cigar blends, restrict store advertising or even place graphic warning labels on the ornate cigar boxes that are coveted by collectors.

    The pushback against FDA rules is also coming from overseas.

    In February, the Cigar Rights of  America organized a letter from the ambassadors of the tobacco-growing nations Honduras, the Dominican Republic and Nicaragua to officials at the White House,  State Department and the FDA, warning that new regulation would threaten thousands of jobs and “raise the specter of political and economic consequences within our region.”

  • Manila FDA will not register e-cigarettes

    The Food and Drug Administration (FDA) announced it will not register e-cigarettes, as health products as these devices are against the intent of the country’s tobacco regulation law, according to a story on MB.com.ph, a Minilan news website.

    In an advisory, FDA acting Director General Kenneth Hartigan-Go said e-cigarettes are “contrary to the intent and provisions of Republic Act No. 9211, otherwise known as the Tobacco Regulation Act of 2003.”

    He said the law aims to protect the youth from nicotine addiction and chronic respiratory ailments including cancer that are caused by inhalation of highly toxic substances found in tobacco and cigarettes. “Wittingly or unwittingly, the electronic cigarette promotes smoking among children and the youth. It makes them less fearful of hazards and risks of smoking. It is opposed to the DOH health goal to stop cigarette smoking and tobacco use,” he said, adding that the FDA has not registered any e-cigarette products and will not register these as health products under the FDA Act of 2009.