Statement of Laurén Doamekpor on the Importance of Including Women, Minorities, and the Elderly in Studies of the Safety and Effectiveness of New Drugs and Devices (FDASIA Section 907 Hearing)

The responsibility of collecting sufficiently representative demographic subgroup data sits solely on the shoulders of device and drug companies. The companies know how to persuade – they do it everyday in commercials. Similarly, if they identify persuasive incentives for patients to participate in studies, and minimize disincentives, patients will participate and be available for follow-up. Continue reading

Statement of Laurèn Doamekpor, Senior Fellow National Research Center for Women & Families Before the FDA Cardiovascular and Renal Drugs Advisory Committee REASANZ (Serelaxin) Injection

March 27, 2014. Statement of Laurèn Doamekpor, Senior Fellow National Research Center for Women & Families, Before the FDA Cardiovascular and Renal Drugs Advisory Committee REASANZ (Serelaxin) Injection Continue reading

Testimony of Laurén Doamekpor, Senior Fellow at FDA Ophthalmic Devices Panel of the Medical Devices Advisory Committee

March 14, 2014   My name is Laurén Doamekpor, and I am a senior fellow at the National Research Center for Women & Families. Our non-profit research center assesses medical and scientific data and provides objective health information to patients, … Continue reading

Testimony of Anna E. Mazzucco, Ph.D. at FDA Advisory Committee on Iontophoresis Devices

February 21, 2014. Class III devices are defined by “potential unreasonable risk of illness or injury”. Based on that definition and the information that was provided to the committee and the public for this meeting, we are convinced, as FDA was for 2 decades, that iontophoresis devices are Class III devices that should be reviewed under the more rigorous PMA process. Continue reading

Coalition Concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013

As members of the Patient, Consumer, and Public Health Coalition, which includes groups representing physicians, scientists, consumers, and patients, we are writing to express our concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013 Continue reading

Testimony of Laurén Doamekpor, Senior Fellow on Inspire Upper Airway Stimulator FDA Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee

February 20, 2014 My name is Laurén Doamekpor, and I am a senior fellow at the National Research Center for Women & Families. Our non-profit research center assesses scientific and medical data and provides objective health information to patients, providers … Continue reading