The US Food and Drug Administration (FDA) issued new rules which will make it easier for seriously ill patients to receive unapproved investigational drugs, in August 2009.
The new rules apply to those patients who have no other treatment options available to them and are not eligible to participate in a clinical trial. There will also be a new website created for patients to find out more about access to investigational medicines.
Manufacturers will be able to charge for expanded access to such drugs, and the FDA hopes the move will encourage more pharmaceutical companies to develop investigational medicines.
The changes will not result in changes to the FDA’s drug approval processes, but are expected to increase applications for investigational drugs by up to 50%.
Further reading - A detailed analysis of the US pharmaceutical market, including some background information on the FDA, is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
Showing posts with label US Food and Drug Administration (FDA). Show all posts
Showing posts with label US Food and Drug Administration (FDA). Show all posts
Friday, 14 August 2009
Wednesday, 5 August 2009
USA - Legislation on Drug Re-Importation Approved
American citizens could obtain drugs from Canada at a lower price, under plans approved by the US Senate. The amendment proposing re-importation passed the Senate by a 55 to 36 vote on 9th July 2009, as part of the Homeland Security funding bill.
Prices of drugs in Canada are far lower than in the United States, and the amendment would allow prescription medicines sanctioned by the US Food and Drug Administration (FDA) to be purchased either in person or over the internet.
The amendment was proposed by Senator David Vitter, who said in a statement, “This is a huge win for Americans concerned about the lowering of the cost of common, expensive prescription drugs and a major defeat for the big drug companies and their powerful lobbying interests.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) opposes re-importation and said that the FDA does not have the resources to monitor the safety of drugs coming into the country.
Currently, American visitors can return from Canada with a three-month supply of drugs, a measure which is supported by the PhRMA.
However, it remains to be seen whether Vitter’s amendment will be kept in the legislation after it goes through the House-Senate talks on a final version of the bill.
Further reading - An in-depth analysis of the US pharmaceutical market, including some background information on legislatory matters, is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
Prices of drugs in Canada are far lower than in the United States, and the amendment would allow prescription medicines sanctioned by the US Food and Drug Administration (FDA) to be purchased either in person or over the internet.
The amendment was proposed by Senator David Vitter, who said in a statement, “This is a huge win for Americans concerned about the lowering of the cost of common, expensive prescription drugs and a major defeat for the big drug companies and their powerful lobbying interests.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) opposes re-importation and said that the FDA does not have the resources to monitor the safety of drugs coming into the country.
Currently, American visitors can return from Canada with a three-month supply of drugs, a measure which is supported by the PhRMA.
However, it remains to be seen whether Vitter’s amendment will be kept in the legislation after it goes through the House-Senate talks on a final version of the bill.
Further reading - An in-depth analysis of the US pharmaceutical market, including some background information on legislatory matters, is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
USA - FDA Panel Votes Against Yondelis for Ovarian Cancer
The US Food and Drug Administration (FDA) voted against recommending approval for Yondelis (trabectedin) for ovarian cancer in July 2009. The drug was submitted by partner Johnson & Johnson (J&J).
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-1 against approval of Zeltia’s Yondelis for the treatment of relapsed ovarian cancer, in combination with J&J’s Doxil/Caelyx (doxorubicin). The drug was shown to have a six-week benefit in progression-free survival in a Phase III trial, but the panel decided this does not justify the use of the drug.
The ODAC also noted that there was a notable increase in severe and life-threatening adverse events in the Yondelis treatment group, including more than twice as many pulmonary embolisms, three times more cardiac adverse events and a higher rate of liver enzyme increases.
J&J’s Centocor Ortho Biotech unit said that it still believes trabectedin “has an important role in the treatment of recurrent ovarian cancer” and “remains committed to working with the FDA to address the committee’s concerns".
Further reading - An in-depth analysis of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-1 against approval of Zeltia’s Yondelis for the treatment of relapsed ovarian cancer, in combination with J&J’s Doxil/Caelyx (doxorubicin). The drug was shown to have a six-week benefit in progression-free survival in a Phase III trial, but the panel decided this does not justify the use of the drug.
The ODAC also noted that there was a notable increase in severe and life-threatening adverse events in the Yondelis treatment group, including more than twice as many pulmonary embolisms, three times more cardiac adverse events and a higher rate of liver enzyme increases.
J&J’s Centocor Ortho Biotech unit said that it still believes trabectedin “has an important role in the treatment of recurrent ovarian cancer” and “remains committed to working with the FDA to address the committee’s concerns".
Further reading - An in-depth analysis of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
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