Drugs

Final Rule, Guidance Issue on Drug Importation

In an abrupt break from decades of prior policy, FDA and HHS announced late 9/24 a final rule that allows FDA-authorized programs to import certain prescription drugs from Canada if specific conditions to ensure the importation poses no additional risk to public health and safety. A final guidance describes procedures for drug manufacturers to import prescription drugs and biologics if they are “FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country,” an agency release says. The rule finalizes a 12/23/19 proposal in the Federal Register that received 1,200 comments.

“The rule allows states (including the District of Columbia and territories), Indian tribes and — in certain future circumstances — pharmacists and wholesalers, to submit importation program proposals to the FDA for review and authorization,” FDA says. “An importation program can be co-sponsored by a state, Indian tribe, pharmacist or wholesaler. Referred to as Section 804 Importation Programs, these programs will be managed by the respective sponsor and any co-sponsors and authorized by the FDA to facilitate the importation of certain prescription drugs that are approved in Canada and, with appropriate labeling, meet the conditions of an FDA-approved drug application.”

Eligible drugs would have to be relabeled with required U.S. labeling and “undergo testing for authenticity, degradation and to ensure that the drugs meet established specifications and standards,” FDA says. “These programs will also have to demonstrate significant cost reductions of the covered products to the American consumer.”

The final guidance also describes procedures for a drug manufacturer to obtain a National Drug Code (NDC) for eligible products that were originally manufactured and intended for sale in the foreign country. “The use of an additional NDC for these products may allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require,” FDA says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome