Wednesday, June 18, 2008
Future Of MA SNPs Hung Up In Medicare Fray
• Future Of MA SNPs Hung Up In Medicare Fray
• Patient Group Advocates Middle Ground On Biogenerics
• FDA Slow On Generic Drug Reviews
• FDA Also Slow In Implementing Post-Market Safety Proposals
• Major Drug Companies Tighten DTC Ad Controls
• Can A Drug Claim To Be A Dietary Supplement?
FUTURE OF MA SNPs HUNG UP IN MEDICARE FRAY
Partisan maneuvering continued this week on a Medicare physician payment relief bill, with a lot at stake for non-physician stakeholders. Among those watching closely are Medicare Advantage special needs plans (MA SNPS).
If Senate Finance Chair Max Baucus (D-MT) can garner more GOP support for his Medicare package, MA SNPs could see a one-year moratorium on new SNP designations and a one-year extension of enrollment restrictions for existing SNPs. Baucus, as well as ranking Finance Republican Charles Grassley (IA) are pulling out all stops, including offering a delay of CMS’ controversial durable medical equipment competitive bidding program as a sweetener to gain support for their dueling Medicare packages.
While Baucus’ Medicare package aims to rein in SNPs, Grassley’s bill is less severe, reports Inside CMS’ Theresa T. Morgan. Grassley would lift the moratorium on new SNPs and expanded service areas for SNPs serving institutionalized populations and dual-eligibles.
Under the Baucus bill, starting in 2010, the state in which an individual resides and an entity other than the plan must decide if a person living in a community but requiring an institutional level of care should be considered a special needs individual. Plus, all enrollees within the MA SNP would be defined as a special needs individual. Grassley would require that 90 percent of MA SNPs’ enrollees are defined as special needs individuals.
For dual eligibles, Baucus would require that a SNP provide each enrollee with a written statement that describes the benefits and cost-sharing protections that the individual is entitled to under the state Medicaid program. The plans would be required to contract with the state Medicaid agency. Grassley would merely require that such plans have a “documented arrangement” with the state, Morgan reports.
And, while Baucus would set limits on cost-sharing for dual eligibles enrolled in MA SNPs, Grassley would merely require that plans make arrangements with providers to ensure they are not charging more than Medicaid. This echoes the stance taken by CMS last month in a proposed rule on Part D and C changes.
PATIENT GROUP ADVOCATES MIDDLE GROUND ON BIOGENERICS
As Medicare stakeholders frantically lobby to get their reforms included in physician payment relief legislation, an equally heated, but less urgent, debate is percolating on the FDA front involving biogenerics. While it is highly unlikely Congress will pass a biogenerics bill this year, the prospect of an Obama presidency has big Pharma nervous an aggressive biogenerics bill may be in the offing for 2009.
House lawmakers recently gathered position papers from stakeholders on all sides of the debate as part of a continued effort to hammer out a compromise.
FDA Week’s John Wilkerson this week reported on a middle ground position staked out by a prominent patient group – the National Organization for Rare Disorders. The group says Congress should allow for interchangeable biogenerics, give innovators a fair amount of time alone on the market before generic competition, let FDA create product approval standards case by case, and separate patent disputes from the review process.
The House Energy & Commerce Committee gave stakeholders until the first week of May to respond to a committee questionnaire, which, not surprisingly, FDA and CMS did not respond to.
The biogenerics debate has been dominated on one side by brand companies seeking to make biogenerics nearly impossible and on the other by generic drug companies and health insurers that don’t want to give innovators market exclusivity. Up to now, patients who want new therapies, but who don’t want to indefinitely pay up to tens of thousands annually for treatments, have been featured less prominently.
NORD’s position is in line with some of the minority members of the Biotechnology Industry Organization, but it is at odds with much of BIO’s position. The patient group’s stance tracks the thrust of bipartisan legislation passed out of the Senate health committee last year.
FDA SLOW ON GENERIC DRUG REVIEWS
Setting up a short-cut for biogenerics approvals, however, does not guarantee FDA would also be speedy in its reviews. Case in point is the current generic drug approval process.
FDA rarely meets the legal deadline for deciding whether to approve new generic drugs, and often doesn’t even start reviews until after they’re supposed to be finished, the HHS Inspector General finds in a new report.
What’s the culprit? Money, according to the IG, which suggests that FDA change the way it prioritizes applications. The IG reports that the number of applications rose 158 percent between 2001 and 2006, while funding for FDA’s generic drug shop grew by only about half that rate.
But lack of money isn’t the only problem. The IG suggests that drug companies—specifically the applications they submit to FDA—share some of the blame. FDA approved only 1 percent of the generic drug applications it reviewed in 2006 and tentatively approved another 3 percent. The remaining 96 percent—946 of 989 applications—were disapproved, reports FDA Week’s Sam Baker.
Chemistry reviewers found problems that led them to disapprove 96 percent of the applications they considered in 2006. In addition to the new applications submitted in 2006, FDA received more than 4,000 amendments intended to correct previously identified deficiencies. Those amendments “compete for the same review resources” as new applications, with so-called “major amendments” going to the back of the line, while “minor amendments” get a place at the front, the IG found.
The IG investigators sampled 105 drugs whose reviews had taken longer than 180 days and found that most of those applications had waited in line for at least 180 days before any division even began its review.
The IG urges FDA look for common problems in rejected applications and issue guidances to help companies avoid those errors. It also says FDA should do a better job prioritizing reviews. For example, if a drug isn’t going to run afoul of another company’s patent, it should be a higher review priority, the report recommends. And if multiple FDA divisions find an application acceptable, the drug should move to the top of the heap, the IG suggests.
FDA agreed on a need to issue guidance for generic drug companies, but said some of the IG’s ideas for prioritizing review “would require a thorough examination of all related issues and policy changes” within the generic drug office.
To solve the money issue, FDA has advocated generic drug user fees similar to those charged brand-name companies. Similar approval delays spurred the brand-name drug industry to support the Prescription Drug User Fee Act in 1992. FDA proposed generic drug user fees in its fiscal 2008 and 2009 budget proposals, only to receive a lukewarm response from the Generic Pharmaceutical Association. Sources told FDA Week in March that talks broke down in part because FDA would not commit to performance goals as part of a user fee package.
FDA ALSO SLOW TO IMPLEMENT POST-MARKET SAFETY PROPOSALS
Another area where FDA has lagged behind—implementing the IG’s post-market safety recommendations. The agency also has not issued a guidance called for by the IG back in 2000 on institutional review boards, and has yet to fix its inconsistent drug registry.
A new IG compendium of unimplemented recommendations complains that FDA hasn’t kept very close tabs on post-market studies, and in some cases could not track the progress of those research projects, reports Baker. Annual status updates from drug companies were often unhelpful or were not submitted at all, the IG said.
Things could change, however, as the FDA Amendments Act gave the agency more authority to require post-market studies, and FDA has also undertaken database upgrades and similar improvements.
But the IG is still worried. “Although we acknowledge FDA’s efforts, we continue to recommend that FDA improve its management information system for monitoring postmarking study commitments,” the IG report states.
FDA also has yet to fix problems uncovered by the IG in 2006 with the National Drug Code. In 2006, the IG complained that more than 9,000 approved drugs weren’t on FDA’s list, while some 34,000 drugs were on the list despite having been pulled from the market. FDA says it will address the problem with a proposed rule late this year or early in 2009.
But the agency has yet to announce any plans to issue a guidance, called for by the IG back in 2000, laying out clinical investigator requirements for institutional review boards. Agency oversight of IRBs, which coordinate clinical trials, has been widely criticized recently, especially in light of fraudulent clinical trials for the antibiotic Ketek.
MAJOR DRUG COMPANIES TIGHTEN DTC AD CONTROLS
Facing pressure from House Democrats, a group of drug makers have adopted stricter limits on the use of doctors in direct-to-consumer advertising. One company, Johnson & Johnson, will also include in its television ads a toll-free number for reporting adverse events, reports Baker.
Last month, House Energy and Commerce Committee Democrats asked four pharmaceutical companies to make specific changes in their DTC policies. All four rejected the most drastic requests but made some concessions.
Johnson & Johnson went furthest, being the only company of the four to include in its TV ads a phone number for MedWatch, FDA’s adverse-event reporting system. Consumer groups have fought hard to make the number a requirement for all ads, but so far have secured a mandate only for print ads.
Schering-Plough said its TV ads will include a statement directing consumers to print ads, which include the MedWatch number. Merck said it would add the phone number to its product-specific Web sites. Both companies, along with Pfizer, said it would be premature to add the number to TV ads because FDA is still studying whether consumers would use the number properly. The agency recently said that study will take two years.
J&J also went further than the other companies by saying it will abide by parts of the American Medical Association’s DTC guidelines, which are more restrictive than those of the Pharmaceutical Research and Manufacturers of America.
Schering-Plough agreed to identify actors who portray doctors in DTC ads, a measure PhRMA President Billy Tauzin has said the trade group would consider adding to its guidelines. The company also said it will disclose payments to real doctors who appear in DTC ads. Merck made the same pledge. Johnson & Johnson stipulated to both of those conditions and also said it wouldn’t use physicians to discuss a product’s benefits. Pfizer said it will ensure that the AMA guidelines “are fully incorporated into our DTC advertising when applicable.”
But the companies balked at lawmakers’ request that they abstain from DTC marketing for two years after a drug’s approval and until a valid post-market study has been completed.
All four companies have run a DTC campaign the Democratic lawmakers believe to be misleading. Meanwhile, PhRMA invited lawmakers to meet with the trade group as it revises its marketing guidelines.
CAN A DRUG CLAIM TO BE A DIETARY SUPPLEMENT?
An interesting new twist in the long-standing battle between dietary supplement makers and FDA over unsubstantiated drug claims: If supplement makers can’t make drug claims, then drug makers shouldn’t be allowed to make supplement claims, a prominent dietary supplement group is telling FDA.
The American Herbal Products Association wants FDA to clarify its enforcement policy on claims made for over-the-counter drug and dietary supplement combinations. AHPA says Bayer Aspirin with Heart Advantage is a drug that makes supplement claims without FDA approval. But Bayer denies it is doing anything wrong.
FDA has traditionally cracked down on supplements that bear drug claims, but until now the table hasn’t been turned. Drug industry lawyers tell FDA Week’s Jennifer C. Smith that the Bayer product might be the first drug touting a supplement property. The aspirin has 81 mg of aspirin and 400 mg of phytosterols and is promoted as an “analgesic phytosterol supplement,” AHPA says.
Tit for tat. In a May 29 letter to FDA, AHPA cites two warning letters the agency has issued to supplement companies marketing OTC drug-dietary supplement combination products without first filing new drug applications.
“If FDA has not changed its policy, we assume the agency should evaluate Bayer’s product in the same manner it evaluated the OTC drug-dietary supplement combinations cited in these previous warning letters. If, on the other hand, there is a new policy, it appears as if the marketplace may now be open to other OTC drug-dietary supplement products,” AHPA President Michael McGuffin says in a statement.
Bayer spokeswoman Anne Colley told FDA Week there is no need for Bayer to file an NDA for its aspirin-phytosterol combination. Bayer did not file an NDA for Bayer Women’s Aspirin Plus Calcium, she noted.--Donna Haseley