Monday, April 28, 2008
Dingell, FDA Chief Spar Over Drug Import Safety
• Dingell, Von Eschenbach Spar Over Drug Import Safety
• Debate Over FDA’s Foreign Inspections Hits The Courts
• FDA Bucks Helsinki Declaration’s Ban On Placebos In Trials
• Maryland Legislation Refuels PBM Transparency Debate
• Idea Of Banning Drug Companies’ Gifts To Doctors Gains Steam
• AHIP Offers Up Data In Bid To Extend Special Needs Plans
DINGELL AND VON ESCHENBACH SPAR OVER DRUG IMPORT SAFETY
This past week featured fireworks on Capitol Hill as House Energy & Commerce Chair John Dingell (D-MI) sparred with FDA chief Andrew von Eschenbach over the safety of imported drugs and food. The seasoned lawmaker and former prosecutor blasted the FDA chief for defending the agency’s import safety plan, while touting his own legislative proposal to significantly boost FDA’s enforcement authority and resources to police the borders. It was a difficult week for FDA, reports FDA Week in a series of articles.
“I didn’t fall off the cabbage wagon yesterday, sir,” Dingell declared at a hearing last Tuesday (April 22). “I’ve been talking to food and drug commissioners for 40 years. And you’re not the first fella that I’ve had to skin for not doing his job and coming up here and defending an indefensible situation. So I want to maintain my respect for you, but I can’t maintain my respect for you if you keep toe-dancing around the hard facts that curse you with the inability to do your job because you don’t have the resources.”
House Democrats desperately want to give FDA more money to carry out inspections. They have support from Congress’ investigative arm, which dug up recommendations it made a decade ago on ways to beef up FDA’s foreign inspection program.
Von Eschenbach, put in a difficult situation of having to defend the Bush administration’s budget request, has been doing a lot of “toe-dancing,” as Dingell puts it. When pressed by lawmakers, he recently admitted that the agency could “handle” more money than requested by President Bush, while still defending the White House request.
FDA also seemed to warm up to Dingell’s idea of setting up an FDA foreign inspectorate. Drug center chief Janet Woodcock acknowledged at a Senate hearing on import safety that FDA has had a hard time getting its inspectors to travel overseas. But she also did a bit of her own “toe-dancing,” saying FDA could neither inspect nor test its way to safety. Woodcock said it’s better to start at the beginning than to test at the end. Any legislation that does not acknowledge quality by design principles will do little to help safeguard public health, she warned the Senate health committee.
House Republicans also entered into the fray. The Energy & Commerce Committee’s top GOP member, Rep. Barton, blasted Dingell for not including Republicans in the drafting of his plan. He protested Dingell’s proposal to charge user fees and as well as the Michigan Democrat’s plan to limit ports of entry. The latter, it seems, would take business away from certain labs in Barton’s home state of Texas. Barton also complained that Dingell’s blueprint ignores his years-long bid to give FDA broader “extraterritorial jurisdiction” to crack down on foreign counterfeit drug producers.
Stay tuned for action from the Senate. Health committee chair Edward Kennedy (D-MA) last week signaled his upcoming import safety bill will cover drugs, in addition to food safety.
DEBATE OVER FDA’S FOREIGN INSPECTIONS HITS THE COURTS
FDA’s foreign drug inspection program, a hot-ticket item over the past two weeks on Capitol Hill, has now reached the courts. Lawmakers are not the only ones frustrated by FDA’s refusal to release its internal inspection work plans for 2001 through 2007. The consumer advocacy group Food and Water Watch, after repeatedly trying to get the documents from FDA, turned to the judicial branch for help this week.
It will be interesting to see if a federal judge buys FDA’s argument that the sought-after documents could be used by terrorists to poison the food supply and by importers to “evade FDA oversight.”
Food and Water Watch sued FDA in U.S. District Court in Washington on Monday (April 28) to hand over the “work plans” the agency used to decide which domestic and foreign food, drug and medical device facilities to inspect from 2001 to 2007, reports FDA Week’s Jennifer C. Smith.
FDA also has refused to release the documents to Senate Democrats Sherrod Brown (OH) and Richard Durbin (IL). A spokesperson for Durbin said the lawmaker has no plans to join the lawsuit.
Food and Water Watch, like the lawmakers, say the documents would help them analyze FDA’s inspection resource needs in light of several high-profile drug and food-related incidents in recent years. “FDA’s ability to ensure the safety of the nation’s food and drug supply with its field activities has come under increased scrutiny after a string of high-profile cases of food-borne illness and drug-related deaths, including E. coli-tainted spinach, salmonella-contaminated snack food, melamine-tainted dog food, and chemically-tainted heparin,” the legal complaint states.
The coveted work plans spell out the number of full-time equivalents each FDA district devotes to regulated product classes, as well as the number of collections, field examinations and product classes each district will concentrate on. The documents, if they show gaps in certain inspection areas, could bolster lawmakers’ press to give FDA more money for enforcement.
FDA BUCKS HELSINKI DECLARATION’S BAN ON PLACEBOS IN TRIALS
FDA on Monday etched in stone its long-held position that it need not abide by the Helsinki Declaration’s ban on use of placebos in clinical trials involving serious or life-threatening conditions when alternative therapies exist. The agency also bucked, in a final foreign clinical studies rule, the Helsinki Declaration’s requirement that companies continue giving trial volunteers the therapy identified as the best treatment once a trial has ended.
FDA says it has no choice under U.S. drug law, which requires that clinical investigations be “adequate and well controlled.” Banning placebos, except when no treatment exists, is inconsistent with U.S. drug law, according to FDA.
But not every agrees – in particular the high-profile consumer advocacy group Public Citizen. The group has long complained that drug companies’ use of placebos in certain trials, especially in poor developing countries, is unethical if alternative treatments exist.
When it comes to the Helsinki Declaration’s call for companies to continue providing treatment once a trial is over, FDA simply sidesteps the issue as outside the scope of its mandate to ensure that drugs work and are safe.
“We do not believe that this rulemaking is the proper forum for debating or resolving issues concerning particular paragraphs of the Declaration, such as use of placebo controls or continued access to therapy after a study is concluded,” the regulation states.
This should come as no surprise to observers. FDA officials have argued for years that it is ethical to use placebos in countries where people can’t afford the alternative treatments. Bob Temple, FDA associate director for medical policy, has stated that, even in cases in which treatments are available for serious diseases, giving placebos to people in poor countries is ethical because trial participants who randomly receive the drug may benefit and those who get the placebo are not any worse off than they would have been otherwise.
Temple also has noted that available therapies are not always reliable, which fogs study results. It may be less ethical to give volunteers available therapies for little return than giving some people placebos in return for improving scientific knowledge, he has said.
FDA’s newly issued regulation, “Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application,” deals with submission of results from foreign clinical studies, which were not conducted under investigational new drug applications, in support of drug and biologics applications.
MARYLAND LEGISLATION REFUELs PBM TRANSPARENCY DEBATE
The Maryland Legislature has refueled a simmering national debate over whether pharmacy benefit managers should be forced to disclose prescription drug data. On April 17, the state became the first to pass through its General Assembly a comprehensive legislative package that imposes significant new disclosure requirements on PBMs. Under the bills, all PBMs must register with the state, disclose certain information before switching a prescription, provide fee schedule information to pharmacies, and ensure that any person responsible for making prescription decisions is properly credentialed.
But the package is certainly not everything PBM regulatory control advocates had hoped for. An advocate who worked on the bills told Inside CMS’ Amy Lotven that the package lacks key provisions that would have made it the preferred model for national legislation.
The bills were created with input from the PBM industry, and represent a “reasonable compromise” on the part of all stakeholders, said an official with the Pharmaceutical Care Management Association (PCMA), which represents PBMs.
Sharon Treat, a Maine legislator who sponsored the country’s first bill regulating PBMs and helped to craft the Maryland legislation, praised the bill as a good step, but said the conflicts of interest section could have been more comprehensive and complained that the plan does not require PBMs to pass-through any manufacturer rebates to plans.
She is also upset the package fails to clarify that a PBM’s fiduciary duty is to the contractor. By not including fiduciary disclosure language, Maryland may be avoiding potential litigation, but sidesteps the one provision that is most effective in regulating the industry, she said.
Treat heads the National Legislation Association on Prescription Drug Prices (NLARx), which focuses on reducing drug prices and expanding access to prescription drugs and worked with Maryland Del. David Rudolph (D) on the PBM package.
Treat’s law in Maine and legislation passed in the District of Columbia both contain the fiduciary disclosure provision, and PCMA sued both states. Maine’s law was upheld, and last year a lower court vacated a preliminary injunction that had blocked the D.C. law from going into effect. The decision was based on the concept of “collateral estoppal,” meaning that because the Maine provision had been upheld in federal court, PCMA could not challenge it again.
On April 18, however, a federal appeals court ruled that PCMA could renew its constitutional challenge against the DC law.
The Maryland legislation was pushed by the state’s Attorney General who in recent years had negotiated settlements with two PBMs—Medco Health Solutions and Caremark Rx—that focused on protecting consumers from having their prescriptions switched, at the direction of PBMs, from lower cost to higher cost medications without medical benefit. If Treat has her way, other states may also consider PBM laws.
IDEA OF BANNING DRUG COMPANIES’ GIFTS TO PHYSICIANS GAINS STEAM
Drug and medical device companies this week faced new pressure – this time outside of Capitol Hill – to cease their popular practice of offering “gifts” to physicians under the auspices of continuing medical education. The Association of American Medical Colleges, after studying the issue for two years, released a report Sunday urging all 129 U.S. medical schools to ban drug and device companies from providing food, gifts and travel to physicians, faculty members and students.
Drug companies, already nervous about legislative proposals gaining steam in Congress, weren’t sure how to respond. CEOs of a handful of prominent drug companies who were on the AAMC task force protested the idea of restricting physicians’ presentations at drug company-sponsored conferences. The trade group representing brand-name drug makers said it would “review” the report. Ken Johnson of the Pharmaceutical Research and Manufacturers of America told The New York Times, “Providing physicians—and medical students—with timely, accurate information about the medicines they prescribe clearly benefits patients and advances health care throughout the United States.”
PhRMA has also been cautious when reacting to lawmakers’ press to sever the financial ties between drug companies and physicians, reports Lotven. A bipartisan, bicameral legislative effort is gaining momentum, and some Washington insiders predict the mandate could be tucked into the Senate’s upcoming Medicare payment bill.
While the transparency initiative is difficult for industry to oppose publicly, privately ndustry officials are more vocal. A Washington insider said she could not see how industry could possibly support the Senate’s Physician Payment Sunshine Act (S.2029) unless it includes key changes, including the addition of a federal preemption clause.
PhRMA hasn’t talked publicly, but a trade group representing medical device companies is telling lawmakers that any federal disclosure law should expressly trump state disclosure laws. Plus, device companies argue that physician-owned manufacturers, distributors and group purchasing organizations should also be covered by the legislation. The device industry also urges lawmakers to protect proprietary interests by stating that disclosure of consulting arrangements related to clinical trials and products under development is not required until the product has been approved or cleared by FDA.
Revisions or not, a Washington insider told Lotven that, with the strong support from Senate Finance ranking GOP member Charles Grassley (IA) and little reason for opposition from House leaders, the prospects of the bill passing this year are very high.
The Medicare Payment Advisory Commission may have some advice on the issue in its upcoming June report to Congress. At an April 9 meeting, MedPAC members debated which federal agency should administer reporting and whether a federal reporting law should preempt state laws.
Cosponsors of the Senate bill include presidential hopeful Sen. Hillary Clinton (D-NY). Ways & Means health subcommittee Chair Pete Stark (D-CA) and Rep. Pete DeFazio (D-OR) introduced a House version, which boasts support from several advocacy groups and stakeholders including Consumers Union, American Medical Student Association, the Medicare Rights Center and the National Physician’s Alliance. Stay tuned.
AHIP OFFERS DATA RELEASE IN BID TO EXTEND SPECIAL NEEDS PLANS
The health insurance industry just upped the ante in its bid to convince lawmakers to extend for several years Medicare’s use of special needs plans: Insurance companies offered to share beneficiary data associated with such plans in exchange for congressional action.
America’s Health Insurance Plans, the health insurance trade group, recently told Senate lawmakers crafting a Medicare bill that they will provide data on outcomes and benefits of special needs plans if Congress lifts the moratorium on new Medicare Advantage SNPs and expands the program.
The AHIP push comes as the Bush administration is resisting efforts to modify the Medicare Modernization Act language in any way and Senate Republicans are saying they don’t want any additional “reforms” tacked onto the Medicare physician “patch” legislation that is moving into the final stage of staff-level negotiations in the Finance Committee.
“So AHIP is walking a fine line,” said one industry insider about the lobbying campaign to reauthorize and expand SNPs.
AHIP said at the recent congressional briefing that a “year by year” reauthorization of the SNP program is “not the way to go.” One reason is that the plans need time to prepare mid-year bids, another is that patient care improvements often take longer than a year, reports Inside CMS’ Brett Coughlin.
According to AHIP data, the latest SNP enrollment from March show 1.13 million Medicare beneficiaries are enrolled in a SNP, including chronic care, institutional or dual eligible plans. The majority of patients—70 percent or 815,000 patients—are enrolled in dual-eligible SNPs. About 175,000 are enrolled in chronic care SNPs and approximately 138,000 in institutional SNPs (nursing homes).
Overall there are 769 different MA plans that offer SNPs, up from 477 in 2007.
Is AHIP’s data release offer enough to convince the Senate Finance Committee to include a SNP provision in its upcoming Medicare bill? AHIP certainly hopes so.--Donna Haseley