Health Policy & Advocacy
Resources
Basic InformationMore InformationLatest News
Will COVID Pandemic's Environmental Benefit Last?AHA News: As Pandemic Disrupts Research, Scientists Look for New Ways ForwardAmericans Lag Behind Brits When It Comes to HealthBan Menthol Cigarettes, Lower Smoking Rates?Tech Is Keeping More Americans in Touch With DoctorsEven Small Reductions in Air Pollution Help The HeartHigh Costs Lead Millions of Americans to Shop Abroad for Rx DrugsPandemic Hits Primary Care Practices Hard Across the U.S.: StudyOne-Time Treatment Eases Parkinson's -- in MiceAHA News: Here's What Doctors Know About Immunizations Right Now – You Still Need ThemDoctors' Choice of Anesthesia Could Help Curb Climate ChangeTough State Gun Laws Help Save Lives: StudyBlood Donors Will Get Results of Coronavirus Antibody Test, Red Cross SaysCOVID Got You Scared of Performing CPR? Study Finds Infection Risk Is LowFor Stressed-Out Black Americans, Mental Health Care Often Hard to Come ByHealthDay In-Depth
The AI Revolution: For Patients, Promise and Challenges Ahead">HealthDay In-Depth
The AI Revolution: For Patients, Promise and Challenges Ahead
Women Still Left Out of Much Medical ResearchHealthDay In-Depth
The AI Revolution: Robots Already Helping Humans Deliver Better Care">HealthDay In-Depth
The AI Revolution: Robots Already Helping Humans Deliver Better Care
HealthDay In-Depth
The AI Revolution: Giving Docs a Diagnostic Assist">HealthDay In-Depth
The AI Revolution: Giving Docs a Diagnostic Assist
AHA News: Calorie Data on Menus Could Generate Significant Health, Economic BenefitsPandemic Has Left Nearly 43 Million Americans Without WorkPeople Are Avoiding the ER During COVID-19 Crisis at Their Peril: StudyAs Postponed Surgeries Resume, Can U.S. Hospitals Handle the Strain?Most Americans Still More Worried About COVID-19 Spread Than the EconomyBig Need for Blood Donations as Postponed Surgeries ResumeEmergency Transport Can Surprise Many With Big BillsOnly Half of Americans Say They'd Get a Coronavirus Vaccine: SurveyIf Prescribed Opioids for Pain, Ask Lots of Questions: FDAState Texting Bans Are Saving Teen Drivers' LivesMillions of Older Americans Can't Get Enough FoodLayoffs and Losses: COVID-19 Leaves U.S. Hospitals in Financial CrisisFDA Goes After Unproven COVID-19 Antibody TestsDuring Droughts, Many Poor Americans Will Lack Clean Tap Water: StudyDid the Movie 'Joker' Reinforce Prejudice Against Mentally Ill?AHA News: How to Get the Most Out of Health AppsCoronavirus Conspiracy Theories Abound, and They Could Cause Real HarmAHA News: Health Emergency? Don't Hesitate to Get HelpAn Expert's Guide to Fact-Checking Coronavirus Info OnlineRacial, Ethnic Gaps in Insurance Put Moms, Babies at Risk: StudyCelebrity Suicides Spawn 'Copycat' Tragedies, Study Shows
The Doctor Gap: In Areas of Greatest Need, Primary Care Is a Team Effort">
The Doctor Gap: In Areas of Greatest Need, Primary Care Is a Team Effort
The Doctor Gap: Where Are All the Mental Health Care Providers?New, Graphic Health Warnings Coming for U.S. Cigarette PacksWith New Boost From Medicare, 'Telemedicine' Steps Up to Fight CoronavirusThe Doctor Gap: In Rural America, It's All Hands on DeckThe Doctor Gap: A Training Program for Country-Doc WannabesDon't Believe All the 'Science' on CBD ProductsMany Car Crash Deaths Involve Alcohol Levels Below Legal Limit: StudyThe Doctor Gap: Does America Have a Physician Shortage?12 Weeks of Paid Maternity Leave Benefits Everyone: Study
Links
Related Topics

Health Insurance
Healthcare

FDA to Allow States to Import Prescription Drugs From Other Countries

HealthDay News
by By Dennis Thompson
HealthDay Reporter
Updated: Dec 18th 2019

new article illustration

WEDNESDAY, Dec. 18, 2019 (HealthDay News) -- Federal health officials have unveiled plans to allow prescription drug imports from Canada and other foreign nations.

The U.S. Food and Drug Administration is proposing a rule under which states could import some prescription drugs from Canada, U.S. Health and Human Services Secretary Alex Azar announced Tuesday.

The agency also plans to make it easier for drug manufacturers to import their own FDA-approved drugs that are manufactured abroad and intended for sale in other countries.

"This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drug makers new flexibility to reduce list prices," Azar told reporters.

Azar touted the proposals as "historic."

All imported drugs would have to be FDA-approved, tested to ensure quality, and relabeled to meet U.S. labeling requirements, added Admiral Brett Giroir, the assistant secretary for health.

State programs created to import medications would be limited to pills that patients would typically get from a pharmacy, Azar said. Injectable products, controlled substances, biologic products and intravenous drugs would not be allowed.

States would create these programs, possibly in conjunction with wholesalers or pharmacies, and then submit them to FDA for approval, Giroir said.

However, drug manufacturers would be able to import any of their own products from other foreign countries, Azar said. That would include products such as insulin, which has recently been subject to steep price hikes.

"Every product is available for importation from every country by a manufacturer," Azar said. "There is no restriction there, if a manufacturer is willing."

The manufacturer pathway is intended to address the "bizarre" system of drug rebates that some pharmaceutical companies have blamed for high prices, Azar said.

"Even if the drug company would like to lower the list price of their drug, they may actually be precluded from doing so because of their arrangements with these middle men, where they have to funnel a certain amount of rebate money to those middle men," Azar said.

Drug companies have said if they can get a new National Drug Code for an imported version of the exact same medicine, then they would compete against their own products at a lower list price, Azar said.

The new proposals are only aimed at brand-name drugs, Giroir said.

"The draft guidance does not address generic drugs because we are not aware of similar private market challenges for reducing the cost of generic drugs," Giroir said.

The FDA is open to considering similar proposals for generic if warranted, he added.

The officials could not say how soon patients will benefit from these proposals, but said that the manufacturer's guidance will likely move faster because it faces fewer regulatory hurdles.

More information

There's more on the rising costs off prescription medicines at Consumer Reports.




328 W. Claiborne St.
P.O. Box 964
Monroeville,
Alabama 36460
Tel: (251)575-4203
Fax:(251)575-9459


powered by centersite dot net