FDA

New VA Study Takes Issue with FDA’s Warnings about Citalopram

By Brenda L. Mooney ANN ARBOR, MI — For nearly two years, the Food and Drug Administration has been issuing safety advisories about the risks of abnormal heart rhythms with higher doses of the antidepressant citalopram hydrobromide. A new study… Read More

FDA’s Role in Protecting US Pharmaceutical Jobs Debated in House Subcommittee

By Stephen Spotswood WASHINGTON — What should FDA’s role be in the continuing globalization of the prescription drug market, and should the agency be obligated to consider the health of the American pharmaceutical industry in any decisions it makes? Those… Read More

Legislation Introduced to Help FDA Prevent and Control Drug Shortages

By Stephen Spotswood WASHINGTON — Unless FDA knows of a potential drug shortage in advance, the agency is not very effective in preventing or controlling that shortage, according to a recent government report. The agency also has failed to keep… Read More

White House Positions on Contraceptives Fuel Controversy on All Sides

By Stephen Spotswood WASHINGTON — Controversy over access to birth control is continuing with the Department of Health and Human Services’ recent decision to cover birth control as a preventive service under the Affordable Care Act. Archbishop Timothy Dolan The… Read More

IOM Says Get Rid of 510k approval FDA Responds Not So Fast

WASHINGTON — Six months after the Institute of Medicine (IoM) issued a report recommending the dissolution of FDA’s 510(k) medical device approval process, the agency has yet to release their official response — a delay that has legislators concerned. Unofficially,… Read More

FDA Is More Bark than Bite on Foreign Drug Imports, Seeks More Authority

WASHINGTON — FDA needs the authority to keep foreign manufacturers who do not comply with regulatory requests from importing their products into the United States, agency officials are telling legislators. Currently, the agency can stop products from entering the country… Read More

Drug Shortages Tripled in Last Five Years; Critical Medications Unavailable

WASHINGTON — The number of drug shortages reported annually has nearly tripled over the last five years, with much-needed drugs such as chemotherapy, anesthetics and electrolytes disproportionately affected. FDA sometimes can mitigate or even prevent a shortage, but this… Read More

FDA Views Future Role as More Than Just Regulator

WASHINGTON — Since taking office, FDA Commissioner Margaret Hamburg, MD, has pushed for science to play a stronger role in the agency, both in the rationale for its decision-making and in meeting its basic purpose.  FDA, she has said,… Read More

Pharmacogenomic Advances Result in Label Changes Decades after Approval

BETHESDA, MD—Even drugs that have been on the market for years, sometimes decades, are not immune from reexamination and relabeling brought about by new scientific discoveries. In the field of pharmacogenomics especially, new opportunities are presenting themselves to use new… Read More

Surgeon General Report Details the Biology of Smoking Damage

WASHINGTON, DC—While the overall negative health effects of smoking have been common knowledge for many years, a newly-released Surgeon General’s report goes into unprecedented detail on how tobacco causes disease at a biological and behavioral level. The report gives fuel… Read More

New Drugs Hold Promise for Veterans with HCV

WASHINGTON, DC—The hepatitis C (HCV) treatment program in VA marks its 10-year anniversary this year on a note of hopeful expectation. For years the only treatment for HCV has been combination pegylated interferon and ribavirin—a treatment with harsh side effects… Read More

FDA Looking to Impact Preventable Medication Harm

SILVER SPRING, MD—“Patient safety is the primary responsibility of everyone who is involved in the healthcare system.” That is the philosophy that underlies FDA’s Safe Use Initiative and what Janet Woodcock, MD, director of the Center for Drug Evaluation and… Read More

Rare Pediatric Disease Research Faces Market, Scientific Barriers

WASHINGTON, DC—Over the last several years, federal agencies have made a concerted effort to direct research and funding to those rare diseases that might not get attention if left to the whim of market forces. For rare pediatric diseases, the… Read More