It's an FDA safety rule, but it seems like drug companies got a lot of what they wanted... They want to make sure the agency is funded so they can get swift approval of drugs...
http://www.bloomberg.com/apps/news?pid=20601202&sid=aFtqgW8Pm8QM&refer=healthcare
President George W. Bush signed legislation today giving the U.S. more power to police the safety of prescription drugs, a response by Congress to concern that regulators haven't acted against harmful medications.
The new law grants the Food and Drug Administration authority to make pharmaceutical companies study the safety of their products after they go on the market. Regulators also could order that warnings be added to prescribing information.
The safety changes are needed because of the FDA's failure to crack down when harmful side effects have been identified in medications, said lawmakers who supported the measure. The agency's performance has been questioned in handling Vioxx, the Merck & Co. drug withdrawn in 2004 after being linked to heart attacks and strokes, and Avandia, GlaxoSmithKline Plc's diabetes pill linked in some studies to a risk of heart attacks.
....
The measure renews and increases fees paid to the FDA by makers of drugs and medical devices, such as pacemakers for the heart, to speed regulatory review. Without new legislation, the fees would have expired at the end of this month.
The legislation had the support of drugmakers and some consumer groups. Others, including Washington-based Public Citizen, said the measure didn't do enough to improve drug safety.
`Lost Opportunity'
``The essential problems in drug safety remain unaddressed,'' said Peter Lurie, deputy director of the Health Research Group at Public Citizen, an advocacy organization, in an interview. ``It's an enormous lost opportunity.''
The legislation will encourage the agency to pay more attention to dangers discovered after approval of a drug, lawmakers said. While drugmakers must complete clinical trials before regulators approve their products, harmful side effects often aren't detected until products are more widely used.
Monday, October 8, 2007
Allegations of Illegal Drug Marketing and Pricing
And then, the pesky Justice Department, cracking down...
WASHINGTON – Bristol-Myers Squibb Company (BMS) and its wholly owned subsidiary, Apothecon, Inc., have agreed to pay over $515 million to resolve a broad array of civil allegations involving their drug marketing and pricing practices, United States Attorney Michael J. Sullivan announced today.
“The government alleges that Bristol-Myers Squibb, among other wrongdoing, fraudulently inflated the cost of a drug used primarily to reduce the side effects of cancer treatments and other generic drugs without regard to the increased costs borne by government health care programs or elderly and indigent patients,” said U.S. Attorney R. Alexander Acosta of the Southern District of Florida. “Corporations cannot continue to mislead the government into paying vastly exaggerated prices by exploiting a health care system based on trust and fair play.”
http://www.usdoj.gov/opa/pr/2007/September/07_civ_782.html
WASHINGTON – Bristol-Myers Squibb Company (BMS) and its wholly owned subsidiary, Apothecon, Inc., have agreed to pay over $515 million to resolve a broad array of civil allegations involving their drug marketing and pricing practices, United States Attorney Michael J. Sullivan announced today.
“The government alleges that Bristol-Myers Squibb, among other wrongdoing, fraudulently inflated the cost of a drug used primarily to reduce the side effects of cancer treatments and other generic drugs without regard to the increased costs borne by government health care programs or elderly and indigent patients,” said U.S. Attorney R. Alexander Acosta of the Southern District of Florida. “Corporations cannot continue to mislead the government into paying vastly exaggerated prices by exploiting a health care system based on trust and fair play.”
http://www.usdoj.gov/opa/pr/2007/September/07_civ_782.html
Is FDA getting tougher?
"Ever since Merck (Charts, Fortune 500) recalled its Vioxx painkiller medication in 2004, the FDA has been stingy about rubber stamping new drugs. CEOs aren't to blame for that - and investors know it."
So, the FDA is more stingy these days, is it? That could be a cause of more lobbying...
http://money.cnn.com/2007/10/01/news/companies/wyeth_ceo.fortune/index.htm?source=yahoo_quote
Lessons from a Big Pharma downfall
Bob Essner deserves a lot of credit for turning around Wyeth. In the end, however, the departing CEO may have been a victim of his own hype, writes Fortune's John Simons.
By John Simons, Fortune writer
October 1 2007: 4:41 PM EDT
So, the FDA is more stingy these days, is it? That could be a cause of more lobbying...
http://money.cnn.com/2007/10/01/news/companies/wyeth_ceo.fortune/index.htm?source=yahoo_quote
Lessons from a Big Pharma downfall
Bob Essner deserves a lot of credit for turning around Wyeth. In the end, however, the departing CEO may have been a victim of his own hype, writes Fortune's John Simons.
By John Simons, Fortune writer
October 1 2007: 4:41 PM EDT
Senator Is Investigating Medtronic Marketing Practices
Grassley looks into whether a Medical device maker is bribing doctors. Will Medtronic's political activity go up? Will there be anything resembling panic in the industry? stay tuned?
Senator Is Investigating Medtronic Marketing Practices
Sen. Chuck Grassley (R-Iowa) sent a letter to devicemaker Medtronic last month saying he is disturbed by allegations that the firm pays doctors “exorbitant amounts of money to encourage the use and promotion of its products.”
The letter referenced an article by The New York Times alleging that Medtronic Sofamor Danek (MSD), a spinal device company, paid a surgeon $400,000 a year for a consulting contract requiring only eight days of annual work.
Tens of millions of dollars a year appears to be paid to doctors through consulting contracts, speaker’s fees and international travel, Grassley said. According to the newspaper reports, these doctors are using Medtronic devices and sometimes promoting the off-label use of the products, he added.
http://fdanews.com/newsletter/article?issueId=10801&articleId=99214
Senator Is Investigating Medtronic Marketing Practices
Sen. Chuck Grassley (R-Iowa) sent a letter to devicemaker Medtronic last month saying he is disturbed by allegations that the firm pays doctors “exorbitant amounts of money to encourage the use and promotion of its products.”
The letter referenced an article by The New York Times alleging that Medtronic Sofamor Danek (MSD), a spinal device company, paid a surgeon $400,000 a year for a consulting contract requiring only eight days of annual work.
Tens of millions of dollars a year appears to be paid to doctors through consulting contracts, speaker’s fees and international travel, Grassley said. According to the newspaper reports, these doctors are using Medtronic devices and sometimes promoting the off-label use of the products, he added.
http://fdanews.com/newsletter/article?issueId=10801&articleId=99214
US FDA Considering 'Behind-The-Counter' Drug Status
US FDA Considering 'Behind-The-Counter' Drug Status - Dow Jones
http://www.nasdaq.com/aspxcontent/NewsStory.aspx?cpath=20071003\ACQDJON200710031031DOWJONESDJONLINE000491.htm&symbol=MRK&symbol=PFE&symbol=JNJ&symbol=SGP&symbol=ABT&symbol=NVS&symbol=AZN&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbo
Drug companies would probably like to be able to sell more drugs without doctors having to give out prescrptions. This seems like it could be a huge boon to the drug industry...
WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration said Wednesday it is considering the possibility of establishing a "behind-the-counter" system that could allow more prescription drugs to be sold without customers actually having a prescription for them.
In a notice set to be published in Thursday's Federal Register, the agency announced a Nov. 14 hearing on the issue. "The FDA is interested in obtaining public comment as it explores the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist," the agency said.
....
n 2005, an FDA panel of outside medical experts turned down a bid by Merck & Co. (MRK) and Johnson & Johnson (JNJ) to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a "behind-the-counter" system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
http://www.nasdaq.com/aspxcontent/NewsStory.aspx?cpath=20071003\ACQDJON200710031031DOWJONESDJONLINE000491.htm&symbol=MRK&symbol=PFE&symbol=JNJ&symbol=SGP&symbol=ABT&symbol=NVS&symbol=AZN&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbo
Drug companies would probably like to be able to sell more drugs without doctors having to give out prescrptions. This seems like it could be a huge boon to the drug industry...
WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration said Wednesday it is considering the possibility of establishing a "behind-the-counter" system that could allow more prescription drugs to be sold without customers actually having a prescription for them.
In a notice set to be published in Thursday's Federal Register, the agency announced a Nov. 14 hearing on the issue. "The FDA is interested in obtaining public comment as it explores the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist," the agency said.
....
n 2005, an FDA panel of outside medical experts turned down a bid by Merck & Co. (MRK) and Johnson & Johnson (JNJ) to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a "behind-the-counter" system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
Pharma, biotech increasingly keen to get together
Pharma, biotech increasingly keen to get together - Reuters
http://www.reuters.com/article/marketsNews/idUKL0314369620071004?rpc=44
Lots of pressure on pharma companies to have new, patent-protected medicines once their patents wear out. They are now looking to snatch up biotech companies... But are they too aggressive?
URICH (Reuters) - Major drugmakers are queueing up to invest in medicines to fill their drug pipelines, biotechs are increasingly keen to do deals and, with 2012 patent expiries looming, prices are set to go even higher, industry insiders said.
"The deal making between pharma and biotech has become a dominant financial force," Peter Reinisch, a partner at venture capital company Global Life Science Ventures, said on the sidelines of a Sachs Associates biotech meeting in Zurich.
AstraZeneca Plc (AZN.L: Quote, Profile, Research) underscored the rush into biotech with its $15.6 billion acquisition of MedImmune this year, which a number of analysts and investors have criticized, arguing AstraZeneca overpaid.
....
Lehman Brothers said in a report last month the price of acquiring promising medicines from biotech firms is soaring, rising by about 45 percent annually over the last three years.
http://www.reuters.com/article/marketsNews/idUKL0314369620071004?rpc=44
Lots of pressure on pharma companies to have new, patent-protected medicines once their patents wear out. They are now looking to snatch up biotech companies... But are they too aggressive?
URICH (Reuters) - Major drugmakers are queueing up to invest in medicines to fill their drug pipelines, biotechs are increasingly keen to do deals and, with 2012 patent expiries looming, prices are set to go even higher, industry insiders said.
"The deal making between pharma and biotech has become a dominant financial force," Peter Reinisch, a partner at venture capital company Global Life Science Ventures, said on the sidelines of a Sachs Associates biotech meeting in Zurich.
AstraZeneca Plc (AZN.L: Quote, Profile, Research) underscored the rush into biotech with its $15.6 billion acquisition of MedImmune this year, which a number of analysts and investors have criticized, arguing AstraZeneca overpaid.
....
Lehman Brothers said in a report last month the price of acquiring promising medicines from biotech firms is soaring, rising by about 45 percent annually over the last three years.
Big pharma vs. generics
Are things getting easier for generics? Big pharma can't like this development. The battle between big pharma and generics goes on....
http://www.bloomberg.com/apps/news?pid=20601202&sid=aeXJBnqXjKB4&refer=healthcare
Generic Drugs May Get Faster Review Under New Rules (Update2)
By Catherine Larkin
Oct. 4 (Bloomberg) -- Generic drugs, priced 30 to 80 percent less than their brand-name counterparts, may get faster reviews under new policies designed to handle hundreds of backlogged applications, U.S. regulators said.
The Food and Drug Administration said today that it is bolstering its generic-drug program by giving priority to decisions on products that are the first of their kind, and by giving applicants more feedback. The policies, some already in place, were designed to shorten the queue of more than 1,300 drugs awaiting approval.
....
The new policies include priority reviews for drugs that are the first of their type and aren't subject to litigation. Previously, the agency reviewed applications in the order they were submitted. The FDA is also shifting to electronic data submission and communications and plans to give more feedback to the industry about how applications should be designed.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aeXJBnqXjKB4&refer=healthcare
Generic Drugs May Get Faster Review Under New Rules (Update2)
By Catherine Larkin
Oct. 4 (Bloomberg) -- Generic drugs, priced 30 to 80 percent less than their brand-name counterparts, may get faster reviews under new policies designed to handle hundreds of backlogged applications, U.S. regulators said.
The Food and Drug Administration said today that it is bolstering its generic-drug program by giving priority to decisions on products that are the first of their kind, and by giving applicants more feedback. The policies, some already in place, were designed to shorten the queue of more than 1,300 drugs awaiting approval.
....
The new policies include priority reviews for drugs that are the first of their type and aren't subject to litigation. Previously, the agency reviewed applications in the order they were submitted. The FDA is also shifting to electronic data submission and communications and plans to give more feedback to the industry about how applications should be designed.
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