Vol. 8 No. 94
The nomination of Margaret Hamburg to be the next FDA commissioner is heading to the full Senate for a vote as soon as today.
The vote had not been scheduled as of late Wednesday, Regan Lachapelle, an aide to Sen. Harry Reid (D-Nev.) told DID. The Senate Health, Education, Labor and Pensions Committee approved President Barack Obama’s choice to head the agency Wednesday. She is expected to win confirmation after a hearing last week in which members of both parties expressed support (DID, May 8).
During the hearing, Hamburg pledged her support for the creation of a pathway for follow-on biologics, saying the drugs could yield significant cost savings for American consumers.
“We need to find a strategy that balances the continuing requirements for innovation with the desire to have more available and more affordable products,” Hamburg testified.
Sen. Mike Enzi (R-Wyo.) urged the Senate to quickly approve her nomination.
“Given Dr. Hamburg’s expertise in emergency preparedness and public health, it is important that the Senate act on this nomination quickly,” Enzi says in a statement Wednesday. “I support Dr. Hamburg’s nomination, and urge my colleagues to do the same.”
With Senate approval, Hamburg will take over an agency that has faced intense criticism of its oversight of drug imports and marketing, financial ties between industry and FDA advisory committee members, and its espousal of federal preemption of state tort laws regarding drug labeling (DID, Oct. 30, 2008).
Acting FDA Commissioner Joshua Sharfstein, who will be Hamburg’s deputy if she is approved, has been leading the agency since last month. During her confirmation hearing last week, Hamburg sought to dispel reports that oversight at the agency would be divided between her and Sharfstein.
“I believe that there were reports in the press that were quite misleading that I would focus on food and tobacco and he [Sharfstein] would focus on drugs,” Hamburg said. “That is simply untrue. I am very eager to take on a broad range of challenges — I would be the commissioner.” — David Belian
The FDA has accepted Amag Pharmaceuticals’ resubmission of its Feraheme NDA, setting a June 29 deadline as its target action date for the iron replacement product.
The company originally submitted its Feraheme (ferumoxytol) NDA in December 2007 and received a complete response letter from the FDA last October. The company responded with a Class I resubmission and received a second complete response letter in December (DID, Dec. 29, 2008).
In the second letter, the FDA asked for data to clarify a specific chemistry, manufacturing and controls question, which the company declined to describe. The agency also asked the company to resolve deficiencies investigators observed during the preapproval inspection of the company’s manufacturing facility and to address labeling concerns.
Feraheme is Amag’s key product candidate and is designed to treat iron-deficiency anemia in chronic kidney disease patients, according to the company’s website. Amag estimates that in the U.S., the population of patients with chronic kidney disease and iron deficiency will include about 354,000 dialysis-dependent patients and 1.6 million Stage 3 and 4 nondialysis patients, according to the company’s annual report.
Amag markets two imaging agents in the U.S. — Feridex IV (ferumoxides) and GastroMARK (ferumoxsil). The company also is studying Combidex (ferumoxtran-10) as an investigational functional molecular imaging agent consisting of iron oxide nanoparticles for use in conjunction with MRI to help differentiate cancerous from normal lymph nodes. — Elizabeth Jones
The HHS Office for Human Research Protections (OHRP) advises clinical trial sponsors that an institutional review board’s (IRB) registration with the office is no guarantee that the board complies with federal regulations on human subject protections.
A registered IRB may not even have the appropriate competence or expertise to review a particular research project, OHRP says. In a second part of the clarification posted on the OHRP website, it says that granting “federalwide assurance” (FWA) to a site also doesn’t prove compliance. The assurance only shows the site’s paperwork is in order, Director Jerry Menikoff told DID this week.
“OHRP wanted to clarify the intent and use of its IRB registration and FWA approval processes for the research community as well as the broader public,” he said.
The clarification was “in part in response to the information presented at the March 26 hearing” of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations. The hearing was held to review an investigation of IRBs, and Menikoff testified about the limits of registrations and FWAs (DID, March 27).
At the hearing, Gregory Kutz, managing director of the Government Accountability Office (GAO) Forensic Audits and Special Investigations unit, testified that his unit created a fake for-profit IRB, whose president was a dog named Trooper and whose staff had names such as April Phuls, and registered it with OHRP.
When subcommittee Chairman Bart Stupak (D-Mich.) asked if the registration of the GAO’s fictional IRB with OHRP constituted a seal of approval, Menikoff replied that the registration system was “more like a phone book.”
IRBs can register with OHRP by emailing their contact details, a system Menikoff said was created as a result of recommendations issued by the HHS Office of Inspector General in 1998. OHRP receives 300 IRB registrations a month this way, but many are renewals, he said.
The GAO investigators were able to use the registration to create an air of legitimacy in online advertising that led a company to offer to submit its clinical trial to the fictional IRB for review, Kutz said.
In another part of the GAO investigation, employees made up a device and asked Coast IRB and two other for-profit IRBs to approve a clinical trial to test it, based on insufficient information. Coast was the only one to approve the purported study, and its CEO, Daniel Dueber, was questioned at the March 26 hearing.
The FDA asked Coast to stop approving new studies and to tell sponsors of studies it was overseeing to stop recruiting new subjects, which reportedly caused an exodus of clients and drove the company out of business (DID, April 15).
“OHRP has also taken specific steps in relation to institutions that had designated Coast as their IRB of record,” Menikoff told DID.
Pfizer’s Pharmacia unit might be forced to pay $212 million in penalties after a Wisconsin jury decided the drugmaker had defrauded the state by charging inflated prices.
Wisconsin Attorney General J.B. Van Hollen requested the amount this week in the Dane County Circuit Court and asked for an injunction requiring Pharmacia, which became a Pfizer unit in 2003, to report truthful prices for its products.
Van Hollen’s request was based on a jury decision in February that Pharmacia caused more than a million violations of Wisconsin’s Medicaid fraud statute, according to a May 12 statement issued by his office (DID, Feb. 19 ).
Pharmacia was one of 36 companies named in a 2004 suit, State of Wisconsin v. Amgen Inc., et al., alleging the generic- and brand-drug makers engaged in an “unlawful scheme” by publishing false and inflated average wholesale prices (AWPs), which became the basis for calculating the cost doctors would charge to administer the drugs to patients, according to court documents.
Each defendant company allegedly provided inflated pricing information for its drugs to First DataBank, which provides states with information on the products’ AWPs, according to court documents. State Medicaid programs rely on the information to reimburse pharmacists.
Through its Medicaid program, Wisconsin purchases more than $610 million worth of drugs, a large number of which are sold by the defendants, according to court documents.
“By willfully engaging in this scheme, defendants have succeeded in having Wisconsin and its citizens finance windfall profits to these providers,” the state alleges in court documents.
Pharmacia had argued that the AWP was a sticker price or a benchmark and that Wisconsin knew it didn’t represent an actual price, according to a statement issued by Van Hollen’s office. The jury didn’t agree with the drugmaker’s arguments.
Wisconsin law provides that a court may impose penalties of $100–$15,000 for each violation of the Medicaid fraud statute, according to a statement.
Baxter Healthcare, Amgen and Immunex have settled with the state without trial, agreeing to pay a total of more than $3 million to resolve their claims. Trials against several other manufacturers are scheduled for next year. — Elizabeth Jones
The European Medicines Agency (EMEA) has issued recommendations on procedures for applicants seeking approvals from the agency’s Committee for Advanced Therapies (CAT).
The recommendations advise applicants that they will be responsible for submitting information to CAT at several points during the approval process and lists target dates for the submissions, according to documents posted on the EMEA website Wednesday.
After submission of an application and the initial CAT review process, applicants should send responses to CAT inquiries — including a revised summary of product characteristics, labeling and package leaflet texts in English on the 121st day of the process.
Before CAT will issue an opinion on the application, the applicant should submit the final draft summary of product characteristics, labeling and package leaflet and, where needed, an updated risk management plan and traceability system on day 171, the recommendations say.
After the application has been approved by CAT and the Committee for Medicinal Products for Human Use, the applicant must submit information to the EMEA.
On day 215 of the process, the applicant should provide the EMEA with a summary of product characteristics, labeling and package leaflet in all 20 of the EU languages. Final translations of this information, including comments received from member states, should be provided to the EMEA by day 229.
Applicants also should provide the EMEA with one final, full-color “worst case” mock-up of outer and inner packaging for each pharmaceutical form by day 246.
CAT reviews advanced therapy medicinal products, which are defined by the EMEA as new medical products based on genes, cells and tissues.
A copy of the EMEA document outlining the updated CAT procedures can be found at www.emea.europa.eu/pdfs/human/cat/63004308en.pdf. — David Belian
Daiichi Sankyo’s hypertension treatment Azor has gained an additional indication from the FDA as a first-line therapy for patients who are likely to need multiple drugs to meet blood-pressure goals.
The approval was based on data from a registrational trial that provided estimates of the probability of patients attaining blood-pressure goals with Azor (amlodipine besylate/olmesartan medoxomil) compared with either of the active pharmaceutical ingredients alone, the company says in a statement Wednesday.
The drug was first approved in the U.S. in September 2007 for the treatment of hypertension — alone or with other antihypertensive agents. Forest Laboratories and Daiichi had a promotion agreement for the drug, which they terminated last year (DID, Aug. 24, 2007).
Adverse effects of the drug include headache, dizziness, dilated blood vessels, and impaired renal function in patients with unilateral or bilateral renal artery stenosis. Pregnant women who take the drug risk the death of a fetus and patients with severe obstructive coronary artery disease may have side effects that include increased frequency, duration or severity of angina or heart attack. — Martin Berman-Gorvine
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