Medical Devices and Prescription Drug Policy

Washington Attorney General Rob McKenna (R-Wash.) said Wednesday that national monitoring of drug prescriptions could stymie fraud and abuse in the Medicaid program, potentially adding momentum to congressional efforts in that direction.

McKenna told fellow AGs gathered for the spring meeting of the National Association of Attorneys General that almost half of prescription drug overdose victims in his state are on Medicaid. McKenna, the association's president-elect, also pointed to a 2009 federal government report that found 65,000 instances of Medicaid beneficiaries in five states improperly obtaining drugs, at a cost of $65 million.

"It would make a lot of sense to create a national database that would respect privacy ... but that would prevent doctor-shopping across state lines," McKenna told The Hill after his presentation. "The states are just now beginning to figure out how to tie their own prescription monitoring databases together. If you could do it nationally — in a way that doesn't create huge unfunded mandates for the states of course — it would make a lot of sense."

Sen. Jay Rockefeller (D-W.Va.) has crafted legislation that would provide $25 million per year to establish state-based prescription drug monitoring programs so states can share information with each other. The bill would also create a national database of prescription drug deaths.

McKenna said he hadn't seen Rockefeller's bill and so couldn't comment directly. But he said Medicaid is a shared responsibility between the federal government and the states because they share the cost, and it is sensible for them to work together to prevent fraud in the program.

"We all support the idea of centralized monitoring to prevent doctor-shopping and prescriber abuse," he said.

A coalition of drug makers and consumer advocates is spreading the word about the Food and Drug Administration's role in the national economy as Republicans weigh sharp cuts to the agency.

The 17-page white paper from the Alliance for a Stronger FDA aims to inform policymakers on the Hill and in the executive branch about the agency's broad reach. The document points out that:

• FDA-regulated industries account for almost 25 percent of consumer spending in the United States;

• The FDA oversees about 167,000 registered domestic food establishments, as well as monitoring 254,000 sites overseas involved in the production and processing of imported food; and

• FDA plays a critical role in protecting the United States against agro-terrorism and bio-terrorism.

"An adequately funded FDA has the potential to be an extraordinary catalyst for the American economy," the report states. "With appropriate funding, the FDA can continue to help drive American innovation and increase the country's competitiveness in the global marketplace, while also serving the public health needs of the American people."

House Republicans last month unveiled a stopgap spending bill for the rest of the fiscal year that would cut $400.2 million from the Obama administration's FDA request for the fiscal year that ends Sept. 30. The FDA had asked for $4.03 billion, a 23 percent increase over fiscal 2010, including $318 million for enhanced food safety regulations signed into law last year.

The alliance's members include a broad array of nonprofit patient advocacy groups, trade associations and companies.

Hundreds of pharmacists are descending on Capitol Hill this week to lobby Congress on bipartisan legislation they say could save the government billions by ensuring patients take their meds.

The lobbying event coincides with a print and radio ad campaign that's ramping up just as the bill has been introduced in both the House and Senate. The legislation would allow Medicare patients who have a chronic condition to review all their medications in one-on-one sessions with pharmacists, helping them stick to their drug regimen.

Sen. Kay Hagan (D-N.C.) introduced the bill last month with three original co-sponsors. Reps. Cathy McMorris Rodgers (R-Wash.) and Mike Ross (D-Ark.) followed suit in the House on Thursday.

Republicans on the Energy and Commerce are still gung-ho about an investigation into drug safety shortcomings that they launched three years ago when they were in the minority.

Committee Chair Fred Upton (R-Mich.) wrote to Food and Drug Administration Commissioner Margaret Hamburg on Wednesday and questioned "the adequacy of FDA's handling" of the inquiry into contaminated heparin from China that killed several dozen people in 2008. Upton gave Hamburg a mere two weeks to turn over all documents concerning the FDA's heparin-related inspections in China and its insights into the sources and methods of contamination.

"It is important to determine how the adulteration happened so that industry and government can take more effective proactive measures to reduce the risk of such adulteration in the future," reads the letter, which was also signed by oversight subcommittee Chair Cliff Stearns (R-Fla.) and Rep. Michael Burgess (R-Texas).

Heparin is a blood thinner made from pigs' intestines that's widely used for kidney dialysis and surgery. More than 80 percent of the U.S. supply comes from China, according to the letter.

Hundreds of people fell ill in 2008 from heparin that officials believe was deliberately watered down with a shellfish-derived supplement to cut costs.

A Government Accountability Office report released last year faulted the FDA for allowing Chinese heparin to be imported into the United States from firms that refused to grant inspectors full access to records and labs. The report, requested by then-ranking member Joe Barton (R-Texas), also faulted FDA's reliance on outside experts with links to heparin companies.

The head of the Food and Drug Administration on Friday told generic drugmakers that the agency is in a "critical time" as dwindling resources and growing demands threaten to delay approval of their products.

FDA Commissioner Margaret Hamburg used her keynote address at the annual conference of the Generic Pharmaceutical Association (GPhA) to urge generic drugmakers to work with her agency as it develops industry user fees that will ensure generics can quickly be reviewed and approved for sale. The FDA is currently seeking to create new fees that will enable generic and biosimilar drugmakers to directly pay the agency instead of relying on annual congressional appropriations.

House Republicans' stopgap budget bill for the rest of the year would cut the FDA budget by $220 million.

"Our resources are already stretched too thin," Hamburg said. "Looking ahead, it's clear FDA will not be able to make ends meet with our current resourcing, and more approvals will be delayed because of a lack of inspectional resources. That's why it's so important that this year — right now — we begin to constructively address the generic drug user fee issue."

The president's proposed budget for 2012 contains $40 million in anticipated revenues from the new fees, which are still being negotiated.

Former Rep. Billy Tauzin (R-La.) joined the Alston & Bird law firm Wednesday, almost one year after stepping down as president and CEO of the main brand-name drug lobby.

Tauzin was a conservative Democrat when he was first elected to Congress in 1980 and helped found the Blue Dog Coalition. He switched parties in 1995.

Tauzin is best known for taking the helm of Pharmaceutical Research and Manufacturers of America (PhRMA) in 2005. He took the position soon after he helped push through Congress a Medicare prescription drug benefit that's widely considered to have benefited the drug industry by not allowing the government program to negotiate prices.

In 2009 and 2010, Tauzin was a key player in Democrats' healthcare reform effort, helping to negotiate a deal in which the drug industry agreed to contribute $80 billion to the effort in exchange for the increased business from the millions of additional insured Americans.

"Alston & Bird is immensely pleased to have a man of Billy Tauzin's ability, experience and drive join our legislative practice," Robert Jones, leader of the firm's legislative and public policy practice, said in a statement. "I don’t think there’s a member of Congress - past or present - who doesn't know Billy's reputation as a dedicated, hard fighter for whatever task he assumes."

A consumer advocacy group is criticizing federal regulators for not extending new limits on acetaminophen to over-the-counter (OTC) drugs.

The Food and Drug Administration (FDA) announced Thursday it is restricting limits of acetaminophen in combination prescription painkillers to 325 milligrams (mg) because of their link to liver damage. Acetaminophen, a pain reliever found in thousands of over-the-counter products, is also combined with other ingredients in many ingredients, usually opioids such as codeine, oxycodone (Percocet) and hydrocodone (Vicodin). Some prescription products can contain up to 750 mg — double of the new FDA ceiling.

The FDA said it sought the new limits because acetaminophen overdoses are associated with serious liver damage.

"There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their healthcare provider," said Sandra Kweder, deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research. "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 mg within a 24-hour period."

A consumer watchdog says the new guidelines ignore the dangers of OTC products, which make up about 80 percent of acetaminophen's market.

“It is inexcusably poor judgment on the part of the FDA to have failed to take action concerning this major source of acetaminophen consumption and, consequently, acetaminophen toxicity,” said Sidney Wolfe, director of Public Citizen’s Health Research Group.

However, the agency is still considering new limits on OTC products, an FDA spokeswoman said.

“There are more complexities in the OTCs and the process of rulemaking occurs over a longer timeframe,” the spokeswoman said.

Higher-dose prescription combination acetaminophen products will be phased out over three years, and the FDA said the new guidelines should not create a shortage of pain medication. The agency is also recommending that boxed warnings — the strongest possible caution for prescription drugs — be added to all acetaminophen prescription products.

The Food and Drug Administration is defending its recent decision to withdraw approval of Avanstin for the treatment of breast cancer in the wake of growing Republican criticism that the decision is a first step toward government rationing.

Richard Pazdur, the FDA's top cancer-drug regulator, told The Wall Street Journal that the decision was not based on the drug's cost — $88,000 per patient per year — but rather with concerns with drug maker Genentech's studies of the drug's benefits. Avastin is still approved for the treatment of four other types of cancers.

Sen. David Vitter (R-La.) has called the decision "sickening" and said it was analogous to the government denying care because the patient's life "is not deemed valuable enough." Other Republicans have also criticized the decision, while cancer experts are split.

"We made the decision because the drug has a marginal effect on tumor growth in breast cancer and in light of Avastin's severe side effects, the risks outweigh the limited benefit," Pazdur told the Journal.

European authorities have not revoked Avastin's approval for breast cancer treatment but have recommended restricting its use so that's only used in conjunction with one type of chemotherapy, paclitaxel.

Federal regulators need another four weeks to review an inhaled insulin product to treat diabetes, the drug's manufacturer announced Tuesday morning.

MannKind Corp. is awaiting a Food and Drug Administration ruling on Afrezza, which would be the first-ever inhalable insulin drug.The inhaler device, which delivers insulin through single-dose cartridges, was rejected by the FDA in March, when the agency requested more information from MannKind.

According to the company, the FDA informed it on Monday night that more time is needed to review the company's new drug application. The company had been expecting a decision sometime this week.

Leading House Republicans accused the Food and Drug Administration (FDA) of rationing care after the agency’s decision Thursday to revoke its approval of an expensive drug for late-stage breast cancer treatment

The FDA said it made the recommendation after reviewing clinical studies that showed Avastin does not prolong overall survival in breast cancer patients or sufficiently slow the disease’s progression. The FDA rejected speculation the decision was based on the treatment’s cost, which can run upwards of $90,000 each year.

However, key Republicans brought back allegations that persisted during the healthcare reform debate that the Obama administration wants to ration care. In a statement issued Thursday afternoon, Republicans pointed out that the European Medicines Agency on Thursday approved Avastin for the same treatment.

“Today, the FDA is withdrawing its approval of a drug that helps prolong the lives of thousands of women living with aggressive breast cancer,” said incoming Energy and Commerce Committee Chairman Fred Upton (Mich.), incoming Health subcommittee Chairman Joe Pitts (Pa.) and Reps. Phil Gingrey (Ga.) and Sue Myrick (N.C.), a breast cancer survivor.

“Unfortunately, this is only just the beginning,” they continued. “The new health reform law — the so-called Patient Protection and Affordable Care Act — creates 159 new boards, commissions and agencies that will destroy the doctor-patient relationship and replace it with federal bureaucrats deciding who gets care and what treatments they can receive.”

Sen. David Vitter (R-La.) argued in July that the FDA wants to ration care after an agency advisory panel voted 12-1 in July to revoke approval of Avastin for treating breast cancer.

Breast cancer advocate Susan G. Komen for the Cure said it was concerned that the FDA’s decision would hinder access to treatment.

“We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, that their insurers will continue to pay for it and that the drug’s manufacturer, Genentech/Roche, continues making the drug available to women through its patient support programs and considers an expanded access program,” the organization said in a statement.

Genentech has 15 days to appeal the FDA decision.