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importation 6 articles

FDA launches program to stop importation of dangerous, ineffective drugs

The Food and Drug Administration (FDA) has implemented a new pilot program designed to crack down on the import of contaminated, misbranded or unapproved drugs into the United States. The Secure Supply Chain Pilot Program will help ensure the safety of drugs manufactured outside the country, but will also help qualified drug companies in the program by expediting their approval processes so that the agency can focus on drugs not in the program that may need closer inspection to ensure safety. In order to qualify to be in the program, pharmaceutical companies must be the sponsor of a New Drug ... Read More

Lawmakers debate safety of importing drugs

Congress continues to debate the notion of allowing people to buy inexpensive drug from other countries, as the Obama administration is encouraging, but the stickler seems to be ensuring the safety of those imported drugs, according to Portfolio. Even on the campaign trail, Obama’s camp said it would support the plan but that there would have to be measures in place to ensure the FDA was properly inspecting the plants where drugs are being manufactured. After all, it was just one year ago that hundreds of people became ill and more than 80 died after receiving injections of the blood ... Read More

New budget supports plan for importation of drugs

As a presidential candidate, President Barack Obama said he supported individuals’ rights to import cheaper drugs from other countries provided the FDA beefed up its inspections to ensure the imports are safe. His new budget plan backs up that claim, according to Reuters. The plan, released earlier this week, says it “supports the Food and Drug Administration’s (FDA’s) efforts to allow Americans to buy safe and effective drugs from other countries.” However, an FDA spokesperson says no details were available on those “new efforts” the agency will undertake to ensure quality control, though a spokesperson with the Department of Health ... Read More

FDA opens offices in India to help oversee drug importation

In an ongoing effort to ensure the safety of foods and drugs imported to the United States, the FDA is opening offices in foreign countries to oversee quality control of those products. The agency announced this week that it has opened two offices in India, according to Med Page Today. Last year the FDA announced it would place more than 60 food and drug regulators worldwide in an effort to keep unsafe drugs out of the country. Late last year the first offices opened in China, a country whose products have made headlines over the past several months for harming ... Read More

FDA launches pilot project to oversee foreign drug products

The FDA announced today that it will launch a voluntary two-year pilot program to help promote the safety of drugs and active drug ingredients made outside the U.S. As part of the Secure Supply Chain program, the FDA will select 100 volunteers to maintain control over drug products beginning with when they are produced until it enters the U.S. The program is designed to assist the FDA in its efforts to “prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program ... Read More

Candidates review reimportation of prescription drugs

Recent scares of tainted medicines and goods from foreign countries, such as contaminated batches of heparin from China, have spurred presidential nominees Sen. Barak Obama and Sen. John McCain to review their support for individuals to import cheaper drugs from other countries, Reuters/Boston Globe reported today. According to the report, aides for both candidates said that recent health scares had dampened their candidates’ enthusiasm of reimportation. Neither candidate has abandoned the prospect; however, they admit it has become a more controversial subject. Other countries, such as Canada, have government price controls that keep prescription drug costs down, making reimportation of ... Read More