The U.S. Senate Finance Committee launched an investigation into Gilead Sciences Inc. GILD -0.24% 's high pricing of the hepatitis C drug Sovaldi, adding its voice to a chorus of criticism accompanying the highest-grossing drug launch in history.
Sen. Charles Grassley, a longtime industry watchdog and member of the committee, and the panel's chairman, Sen. Ron Wyden, sent a letter to Gilead Chief Executive John Martin on Friday announcing the probe and requesting a wide range of documents on how the Foster City, Calif., company decided on the price. Sovaldi costs about $1,000 a pill, or about $84,000 for a patient on a standard, 12-week regimen.
The letter from Sens. Grassley and Wyden asks for substantially more information from Gilead to justify Sovaldi's price. The letter asks 21 questions, seeking answers in the form of documents, including those related to Gilead's 2011 agreement to shell out $11 billion to acquire Pharmasset, the smaller company that developed Sovaldi.
The request seeks documents detailing Pharmasset's more modest pricing assumptions for Sovaldi. The senators noted that Pharmasset, in a 2011 filing with the Securities and Exchange Commission, assumed a Sovaldi U.S. base price of $36,000 per course of treatment in a financial forecast model.
The senators asked Gilead for copies of written communications with its bankers on the Pharmasset deal, Barclays and Bank of America Merrill Lynch, related to the valuation of Pharmasset and pricing assumptions for Sovaldi. They also asked for an accounting for Gilead's research costs related to Sovaldi following its purchase of Pharmasset. A Bank of America spokesman declined to comment. A Barclays spokesman declined to comment.
The senators' letter asks Gilead to begin producing the requested documents and information two weeks after receiving the letter and to complete the request within two months.
The letter also raises concerns about potential conflicts of interest.
Earlier this year, the American Association for the Study of Liver Disease and the Infectious Disease Society of America jointly issued treatment guidelines that recommended Sovaldi for certain patients. The senators said that 18 of the 27 members of the expert panel that developed the guidelines have either a direct financial relationship with Gilead or work for institutions that have received funding from Gilead.
The senators asked for an itemized accounting of all payments from Gilead and Pharmasset to the panel members and those organizations since 2009.
The AASLD and IDSA said in the treatment guideline report that the panel excluded anyone who had an ownership stake in—or worked directly for—companies making hepatitis C drugs or who were paid to give promotional talks. The panel did include some members whose institutions received research funding from the companies or who participated in company advisory boards, as well as members who received payments from Gilead for consulting and advisory services.
My personal opinion.besides this pricing investigation is that the government should pass a law or the FDA should require the reporting of major side effects and SVR rates for any new fast track drug approval.
All treatment providers would be required to electronically file a report to a national data base within 30 days after 12 week SVR test result is known. It would protect the patients privacy and only include similar information that a trial reports including major side effects. The FDA would be required to make updated cumulative totals with percentages available to the public online within 30 days of receiving the information.
In the trials we all were excited about the high 90's SVR rates with the biggest numbers from those with out cirrhosis and treatment naive. There were even high numbers for some with cirrhosis and prior non responders.
In the post approval era we may very well see a lower percentage achieving SVR especially those with cirrhosis, prior treatment and other serious co existing conditions than were shown in the trials.
Without a strict and timely results reporting requirement drug companies may be very slow in reporting poorer results. We have seen it in the past with other drugs(some new and others even out for years). Just look at GM and the auto industry. Big Corporations (big money) needs to be held more accountable.
For some who don't need to be treated now or very soon, have very little progression of liver disease and don't have other conditions that suggest treatment now, it may be better to wait for tx up to a year or so in my opinion. They still should be closely monitored for any increasing rate of progression of liver disease or other related conditions.
Any other gt 1a, treatment experienced people starting to feel like the promised date of delivery for Sovaldi+Ledipasvir will be delayed for months due to legal rangling. This is enough to **** me off.
"the FDA should require the reporting of major side effects and SVR rates for any new fast track drug approval."
The two things are mutually exclusive. Major side effects can manifest years down the line which could make fast tracking impossible. Gilead's pricing compared to Pharmasset's was partially affected by the projected release of possibly better products in the near future among other things. This is what happens when you mix a market economy with medicine.
Current FDA regulations do require reporting of adverse events both during the clinical trial process, and any that become known to the company after approval. Doctors and patients can elect to report those directly to the FDA if they so chose. The manufacturer also reports updated clinical data annually, also required by existing regulations.
48weeks, In my personal opinion, I don't believe this investigation will have much if any impact on the fast track approval time frame for Ledipasvir.
desrt let me restate that. After a drug is approved by the FDA through the fast track path. All treatment providers would be required to electronically file a report to a national data base within 30 days after a 12 week SVR test result is known. They would also be required to report any serious life threatening side effects or death within 30 days after they become aware of that during or after treatment. They would also be required to advise the patient's primary doctor to notify them and or report if they are no longer treating that patient
"Doctors and patients CAN elect to report those directly to the FDA"
Trust the doctors some of which have a financial interest and/or some other hidden relationship with ???
Doctors should be required to report within 30 days after becoming aware of them.
Yes, trust the manufacturer who doesn't have to report for a year after approval.
Fast tract approval is about 8 months time between filing and approval if everything goes smoothly. Yet the manufacturer also reports updated clinical data annually. So it would be more than a year after approval before they have to report NOT FAST ENOUGH
I am not implying that this applies to Sovaldi and Gilead. I believe the mostly great SVR rates with Sovaldi with minimal side effects will continue and no more serious side effects will become known in the future. There may be some treatment tweaking needed for some HCV patients groups.
But it could be very convenient for some companies to have a year or more to make as much money as possible especially if a drug might be recalled in the following year. No I really don't believe this applies to Sovaldi but it has happened in the past with a few other drugs. So there is need for some more faster reporting of new drugs and release of that information to the public.
This is my opinion and just a general idea. I am not a medical professional and don't imply that the specific methods and time range in my example should be adapted as is. But some better and more timely system is needed.
I have recently read that fraud in the medical industry either by companies and or medical providers and or patients may exceed 100 Billion Dollars a year in the USA Just think if just another 50 Billion could be made available to those who who do not have the resources to get proper medical treatment
Best wishes for all to get the right treatment in time to achieve SVR, minimize the HCV risk of death and live as long as possible.
Political posturing....find out who is behind Sens. Grassley and Wyden's request for a probe and then talk about 'conflict of interest'. Who do they want to be on the board for AASLD and IDSA......the CEO of NY Times?
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