Monday, March 31, 2008
FDA Preemption Debate Reaches New Heights
•Scalia Says Media, Democrats Politicized Preemption Ruling
•Commissioner Pleads For FDA Employees To Trust Him
•FDA’s Ties To Industry Questioned, Again
•Amgen V. Roche Lawsuit Broaches Compulsory Licensing
•Tamper-Proof Rx Pad Policy Goes Into Effect
•Bush Administration Buys Time To Release AMP Policy Data
SCALIA SAYS MEDIA, DEMOCRATS POLITICIZED PREEMPTION RULING
Supreme Court Justice Antonin Scalia clearly isn’t amused by the media frenzy and congressional activity surrounding the Supreme Court’s decision to uphold FDA preemption of state medical device laws. The New York Times suggested the high court revealed its trust in FDA, and key Democrats charged the court misinterpreted congressional intent and then promptly wrote legislation to reverse the ruling. A lot of hoopla for the wrong reasons, Scalia told industry lawyers last week.
The high court’s decision in Riegel v. Medtronic had little to do with big-business friendliness or faith in FDA, Scalia said—it was simply a matter of reading the law.
Scalia spent the better part of his prepared remarks at last week’s Food and Drug Law Institute meeting chastising the media, reports FDA Week’s Sam Baker. With particular scorn for a New York Times piece, he said the decision had been portrayed as a reflection of the justices’ confidence in FDA. In reality, Scalia said, the Riegel decision reflected an unremarkable determination that a federal prohibition on many state “requirements” included common law.
“Justice Scalia’s faith in the F.D.A. far outstrips our own,” the Times editorial board stated on Feb. 22, two days after the Supreme Court handed down its decision.
Scalia brushed off that assertion, saying his relative faith in FDA was irrelevant. Congress wrote a law that preempted state “requirements,” and the high court has routinely held that state tort suits constitute a requirement. He charged that the newspaper’s editorial board “seems utterly unaware that a text-based approach is even possible.”
Scalia suggested lawmakers were also off base. He criticized Rep. Henry Waxman (D-CA) and Sen. Edward Kennedy (D-MA) for trying to sway the court by filing an amicus brief stating that Congress never intended for medical device law to preempt state tort suits, only statutes. Scalia called the brief “unusual” and said the only way the court should interpret congressional intent is by reading the laws that Congress passed. “I don’t care if they had some secret understanding of those words,” Scalia said. “That’s not the law.”
“Riegel was a forthrightly textualist decision,” according to Scalia, who wrote the majority opinion in Riegel, in which the justices ruled that FDA regulations preempt state tort suits involving approved medical devices. Scalia said the court’s 8-1 decision was the only logical conclusion to reach from a literal reading of the Medical Device Amendments, which include an express preemption clause.
Scalia, however, praised Times reporter Linda Greenhouse and the Wall Street Journal editorial board for at least describing the relevant statute. If voters come to believe that judges will do whatever they want, irrespective of legal text, they will feel that working through the democratic branches is futile, Scalia said.
Riegel was the first of three FDA preemption cases the court has agreed to hear in relatively short order. The justices were split 4-4 over a narrow case involving drugs, and will hear another drug-related case in its next term.
At least one state is watching every twist and turn of the high court’s deliberations. Anticipation of a Supreme Court drug preemption ruling played a role in Alaska’s decision this month to settle a lawsuit with Eli Lilly. The state agreed to a $15 million settlement, significantly less than it was seeking in a lawsuit over Zyprexa, a schizophrenia drug, reports Baker.
Lawyers in the case told The New York Times they were quick to settle partly because they feared that a prolonged trial could keep the case active while the Supreme Court weighs Wyeth v. Levine, a drug preemption case, in the fall. “We had this issue with the Supreme Court deciding preemption this fall that could have completely unwound any victory we might have had,” an Alaskan assistant attorney general told the newspaper.
Other courts are also watching. That Supreme Court case might be the only way to convince one Pennsylvania judge that FDA regulations preempt state tort suits. In a March 14 opinion in Clark v. Pfizer, a state judge wrote that states have an obligation to protect their residents, and that his court is therefore “obligated to enforce state law until such time as the Supreme Court of the United States having actual authority determines that state law has been preempted.”
Preemption was tangential to that case, but was central to another decision, also in Pennsylvania, three days earlier. The judge in Collins v. SmithKline Beecham, which involved suicide risk from antidepressants, declined to consider FDA supporting briefs and ultimately rejected preemption.
Prior to this month’s decisions in Pennsylvania, 2008 had been kind to FDA and preemption advocates. They scored five consecutive victories in Oklahoma, California, Ohio and Michigan.
COMMISSIONER PLEADS FOR FDA EMPLOYEES TO TRUST HIM
As FDA battles for state courts to defer to federal regulatory policies, the agency’s chief is engaged in a private battle to get his own employees to “trust” him. FDA’s scuttled move to close many of its regional labs riled regional officials, and agency chief Andrew von Eschenbach received an icy reception while giving a speech at FDA’s Atlanta complex March 11. Von Eschenbach tried to lift his troops’ spirits with an e-mail telling them they should trust that things will get better.
Consumer groups and Democratic lawmakers have long complained of low morale among FDA employees, and the commissioner’s e-mail indicates that FDA employees are still distrustful of agency brass, reports FDA Week’s John Wilkerson.
Von Eschenbach delivered brief remarks in Atlanta, expecting a lively question-and-answer session to follow. Instead, he was met with “polite silence,” according to his FDA-wide e-mail with the subject line “Acknowledging, Learning, and Moving On.” In response to the few questions he received, the commissioner tried to spur on discussion with long answers, but to no avail.
“And then a light went on in my head,” he wrote. “Perhaps this disconnect was a reflection of some skepticism or uncertainty about the genuineness of my concern and commitment to admit that the design of our first effort at ORA transformation was flawed and let go of this old design and move on to a new plan. Perhaps rather than boredom or apathy, the real reason for the audience seeming detached could be a lack of trust that we could all move on--all of us.”
FDA was forced to back off plans last year to close seven of its 13 field labs after Congress blocked the scheme. The plan also included closing five of the agency’s regional offices and four of its 20 district offices. During the fight with Congress last summer, von Eschenbach and Margaret Glavin, who leads the Office of Regulatory Affairs, testified in support of the lab. Following the congressional hearing, lawmakers accused Glavin of retaliating against several lab directors who testified against her plans.
Eschenbach has been trying to keep his troops in line for some time. Earlier in 2007, von Eschenbach was asked by lawmakers to explain what he meant by telling a small group of drug center staff they might find themselves “off the team” if they spoke outside the “locker room” about the approval of the antibiotic Ketek. FDA whistleblowers perceived his remarks as threats.
FDA’s handling of whistleblowers in recent years has also spurred Congress to consider specific protections for scientist whistleblowers.
FDA’S TIES TO INDUSTRY QUESTIONED, AGAIN
FDA faced new questions this past week over whether its ties to industry have tainted its ability to ensure drug safety.
The agency touted a new “Safety First” plan to beef up the agency’s safety oversight, only to find it sharply criticized by GOP Sen. Charles Grassley (IA) as a cosmetic gesture that fails to fix drug reviewers’ stronghold on post-market drug oversight. To make matters worse, days later a New England Journal of Medicine article suggested FDA’s long-standing drug user fee program, which uses industry funds to pay for drug reviewers, is partly responsible for recent drug safety problems.
The agency also likely raised eyebrows on Capitol Hill when it told industry lawyers last week that it was relying on drug industry funds to sidestep a congressional ban on FDA funding for the Reagan-Udall drug research initiative. Key Democrats, who originally authorized the program, now charge the government-industry partnership aligns the agency too closely with the industry it regulates, reports Wilkerson.
Agency officials told industry officials attending the Food and Drug Law Institute’s meeting in Washington that closer FDA ties to industry are a reality that stakeholders should get used to.
FDA also reacted negatively to the NEJM article, charging there are “fundamental problems” with Harvard University researchers’ finding that the drug user fee program has contributed to a rise in safety risks. The agency has yet to reveal what those fundamental problems are, but says it will deliver its own analysis to NEJM and also release its data publicly, reports Baker.
The agency may also soon face new questions about its handling of data suggesting the cholesterol-lowering drug Vytorin is no better than a generic alternative in reducing plaque build-up. FDA has received letters from both sides of Capitol Hill on the issue, and on Monday Senate Finance GOP leader Grassley unveiled internal documents suggesting Schering-Plough Corporation and Merck & Co. budgeted $3.5 million for a six-week campaign to entice doctors to switch patients from cheaper statins to Vytorin.
The Vytorin flap is now moving to CMS’ turf. Grassley suggests the companies’ marketing efforts may have led Medicare and Medicaid to be charged unnecessarily for cholesterol-lowering treatment. Is Grassley – a well-known advocate of expansive use of the False Claims law – laying the grounds for someone to file a new False Claims suit? Time will tell.
AMGEN VS. ROCHE LAWSUIT BROACHES COMPULSORY LICENSING
Will Amgen’s patent infringement case against Roche establish a precedent for compulsory licensing of pharmaceuticals? Manufacturers and Wall Street analysts are closely watching the two companies’ ongoing battle over Roche’s Mircera, which according to a Boston district court jury’s verdict last October infringes on Amgen patents for erythropoiesis-stimulating agents (ESAs) Epogen and Aranesp.
The case took a turn after oral arguments held Feb. 28. A day later, U.S. District Court Judge William Young said that while “the balance of hardships as between Amgen and Roche weighs in favor of an injunction” against Roche’s Mircera sales, he still struggled with whether “the public interest would not be disserved by a permanent injunction.”
Instead of barring the sale of Mircera, Roche could be required to pay Amgen a 22.5 percent royalty and keep Mircera’s Medicare average sales price below Epogen’s, Young noted. In subsequent briefs, Amgen opposed the proposal while Roche lent its support. Amgen previously dismissed Roche’s offer of a 20 percent royalty as “grossly inadequate.”
Then, on Wednesday, Young ordered the appointment of a “special master” to make recommendations on price parity and dose conversion ratios for Epogen and Mircera, which is administered less frequently than other ESAs. Amgen and Roche were given 15 days to suggest options. Once appointed, the “special master” will have 60 days to finish a report.
The outcome of this case, and in particular the discussion of “public interest,” could significantly affect other patent disputes.
TAMPER-PROOF PAD POLICY GOES INTO EFFECT
Beginning April 1, Medicaid providers are supposed to use only tamper-proof pads when writing prescriptions. Some stakeholders aren’t happy.
“People are bracing for the fall,” one Medicaid director tells Inside CMS’ Amy Lotven. “Remember Part D.” Meaning, remember the start-up chaos surrounding the hastily prepared 2006 Medicare addition of a drug benefit.
Granted, some Medicaid directors, providers and pharmacists are more confident that the move toward tamper-proof prescription pads will be an instant success. Doctors and pharmacists have been educated about the new requirement, included in last summer’s war supplemental, and compliant pads have been on sale for a while.
Still, the reform’s effect on pharmacists will be hard to gage immediately, a pharmacy representative said, especially because it remains to be seen how vigorously the new policy will be enforced and non-compliant providers will be penalized. Last year, concerns by pharmacy groups drove Congress to delay the tamper-proof pad requirement by six months.
How should pharmacists prove to their state that they confirmed a prescription with the appropriate doctor – and thus are eligible for reimbursement – in cases where the prescription wasn’t written on a tamper-proof pad, or the pharmacist isn’t sure it was? Under the new CMS policy, pharmacists must contact the prescribing doctor within 72 hours in such cases. Must pharmacists now keep a phone log of these calls?
These and other wrinkles may have to be worked out on the go.
BUSH ADMINISTRATION BUYS TIME TO RELEASE AMP POLICY DATA
CMS will have 60 more days to release the data it used in drafting last year’s controversial rule on drug-specific average manufacturer prices (AMPs). A judge had ordered CMS to release the data by the end of March, but pharmacy and Bush administration lawyers agreed Monday night on an extension.
The data release is at the heart of a case community and chain pharmacists brought last November against CMS. Pharmacists questioned CMS’ view that the AMP reform would not threaten the livelihood of retailers, especially smaller retailers. The agency never released data in support of its claim, pharmacists argued while pointing to reports by the Government Accountability Office and HHS Inspector General that indicate the AMP policy would drastically cut pharmacists’ Medicaid reimbursements.
A U.S. District Court judge has blocked CMS from implementing the rule, which has also been criticized by pharmacy benefit managers and manufacturers. Just last month, CMS itself backtracked from a multiple-source drug definition included in last year’s AMP rule.
Several other recent CMS rules have drawn fire from small business advocates, including those implementing a laboratory competitive bidding demonstration and requiring durable medical equipment suppliers to post surety bonds to ensure that Medicare can recover up to $65,000 in erroneous payments that result from fraudulent or abusive billing practices. CMS’ release of internal documents on its AMP policy will not just be a huge victory for pharmacists. It may also fuel other groups’ data queries.--Donna Haseley and Rolf Rosenkranz