‘First Of Its Kind’ Service Launches To Support Drug Labeling Compliance Rule

‘First Of Its Kind’ Service Launches To Support Drug Labeling Compliance Rule

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Pharmaceutical companies can now take advantage of that established expertise to save an enormous amount of time.

“It’s the first service of its kind to aid pharmaceutical companies in this way,” described Stephen Braddock, MD, a St. Louis-based pediatrician and dysmorphologist in reference to a new endeavor offered by birth defects experts at the Organization of Teratology Information Specialists (OTIS). The unique offering aims to support the implementation of the FDA Pregnancy and Lactation Labeling Rule (PLLR) pharmaceutical companies now must adhere to, creating an urgent need for fetal and lactation risk summaries on thousands of medications.

The PLLR implementation requires the revision of product labeling for all drugs approved after June 2001. “Thousands of prescription medications fall under the PLLR timeline over the next five years, an overwhelming task for many companies,” added Dr. Braddock, who also serves as the OTIS president. OTIS, Inc. is a wholly owned Benefit Corporation established by the non-profit OTIS. “OTIS experts can step in to provide current reviews of existing data and comprehensive risk summaries pharmaceutical companies are under pressure to produce.”

Thorough literature reviews, synthesis and translation of the data are all part of the

OTIS communication process already, according to Melissa Tassinari, PhD, a retired Sr. Clinical Advisor for the US Food and Drug Administration and founding PLLR project leader. “OTIS has been communicating pregnancy and lactation risk exposure through its MotherToBaby helpline service for more than 30 years,” explained Dr. Tassinari. “Pharmaceutical companies can now take advantage of that established expertise to save an enormous amount of time.”

Christina Chambers, PhD, MPH, an epidemiologist and OTIS, Inc. board ad hoc advisor said the process for assistance will begin with a quote, which pharmaceutical companies can request via MotherToBaby.org/OTISInc or by emailing contactus(at)otispregnancy.org. The rest of the literature review process will be carried out painlessly, timely and accurately. “To develop OTIS, Inc. we were supported by an advisory board comprised of the world’s leading experts in the area of prenatal risk exposure with extensive backgrounds in academia, research, government and industry to ensure that the highest quality product possible will be delivered,” she said.

The full OTIS, Inc. Board includes:

  •     Stephen R. Braddock, MD, OTIS President
  •     Melissa S. Tassinari, PhD, retired Sr. Clinical Advisor, US Food and Drug Administration
  •     Sarah G. Obican, MD, University of South Florida Morsani College of Medicine
  •     Katherine L. Wisner, MD, MS, Northwestern University Feinberg School of Medicine
  •     Christina D. Chambers, PhD, MPH, OTIS President-Elect, Ex-Officio Member

OTIS, Inc. Advisory Board members include:

  •     Philip O. Anderson, Pharm D, Author of LactMed® database
  •     Gerald G. Briggs, B Pharm, FCCP, Co-Author of Drugs in Pregnancy and Lactation
  •     Cheryl S. Broussard, PhD, Centers for Disease Control and Prevention, NCBDDD
  •     Alicia B. Forinash, Pharm D, FCCP, BCPS, BCACP, Co-Author of Drugs in Pregnancy and Lactation
  •     Jan M. Friedman, MD, PhD, TERIS Principal Investigator
  •     Janine E. Polifka, PhD, TERIS Project Director
  •     Anthony R. Scialli, MD, Reprotox® Director

To read more about the product service offered by OTIS, Inc., please see its digital prospectus here.

More about OTIS

The Organization of Teratology Information Specialists (OTIS) is a professional scientific society made up of individuals engaged in assessing and evaluating risks to pregnancy and breastfeeding from environmental exposures. Members include, but are not limited to, specialists in the fields of: obstetrics and gynecology, pediatrics, genetics, dysmorphology, perinatal epidemiology, teratology, behavioral teratology, pharmacy, genetic counseling, nursing, midwifery, maternal and child health, public health, and includes experts that provide MotherToBaby services and researchers that conduct MotherToBaby Pregnancy Studies. MotherToBaby is a suggested resource by many federal agencies including the Centers for Disease Control and Prevention (CDC).

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Media Contact: Nicole Chavez, 619-368-3259, nchavez(at)MotherToBaby.org

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