US Capitol Capsule: Health reform draws amicus attention, but most Americans 'meh' on impact

As Republicans keep pounding away through the legislative process in attempts to kill off bits and pieces of the 2010 health care reform law – which celebrates its two-year anniversary this week – the time draws nigh for the question of its constitutionality to go before the US Supreme Court, which will hear six hours of oral arguments next week presented over three days, beginning 26 March.

The court is expected to make a decision by the end of June – the close of the justices’ current term.

Many court watchers have predicted a close 5-4 outcome, although opinions vary on what side of the argument the gavel will fall for the Patient Protection and Affordable Care Act.

On the line for the Obama administration is whether Congress had the authority under the Commerce Clause of the US Constitution to require US taxpayers making at least $18,000 annually to maintain minimum essential insurance coverage for themselves and their dependents by 2014 or pay a penalty of 1% of their family income or $95 per family member, whichever is greater, with that figure rising to 2% of income or $325 per family member in 2015, topping out at 2.5% of income or $695 per family member in subsequent years.

That question is at the heart of the landmark lawsuit brought by Florida and 25 other states, which are arguing that Congress does not hold the power to compel American taxpayers to engage in commerce to more effectively regulate commerce and that such authority does not exist (scripintelligence, 9 January 2012).

The high court's ultimate determination could not only impact the individual mandate, but it could potentially uphold or strike down the entire law.

The justices must first determine the Anti-Injunction Act question of whether the Supreme Court can even consider the constitutionality of tax penalties that have not yet been imposed.

The court has dedicated 90 minutes for oral arguments on that question on the first day, while the minimum coverage provision gets a full two hours on 27 March.

At risk for the innovator biotech industry is the loss of the 12 years of data exclusivity protection it won against biosimilars if the entire law is overturned. The potential millions of new prescription customers through the state-based health insurance exchanges also could be gone for drug makers, unless the justices determine that the other measures in the health reform law can be severed from the individual mandate.

The severability question will be heard over 90 minutes of oral arguments on 28 March. The last hour of the oral arguments will be devoted to the question of whether the health reform's expansion of Medicaid violates US states' sovereignty by forcing them to spend more of their funds on the program.

Because the health care reform law has ramifications for the entire US, Senator Charles Grassley (Republican-Iowa) had led the charge to try to get the oral arguments videocast live – arguing that "cameras in federal courtrooms are at the very heart of an open and transparent government."

"Broadcasting the health care reform law proceedings would not only contribute to the public's understanding of America's judicial system, but provide an excellent educational opportunity on a case that has the potential to have a far reaching impact on every American," Mr Grassley contended.

Indeed, polling results reported last week by the Kaiser Family Foundation found that many Americans remain confused about the Affordable Care Act, with 14% of respondents believing the Supreme Court already had overturned it.

But Supreme Court Chief Justice John Roberts informed Mr Grassley on 16 March that cameras would not be allowed in the courtroom. Chief Justice Roberts, however, is permitting audio recordings of the oral arguments to be made available later each day following the proceedings.

Other results from the Kaiser poll showed that only one in four respondents were aware that the Patient Protection and Affordable Care Act has lowered prescription drug costs for seniors through the gradual closing of the so-called Medicare doughnut hole, and that the law also eliminated cost-sharing for certain key preventive services.

The Kaiser survey also showed that 51% of Americans think the individual responsibility mandate is unconstitutional, with only 28% responding that it falls in line with the US Constitution. About 21% either declined to respond or said they did not know enough about the law to provide an answer. The poll also reported that 53% of Americans expect the individual mandate to be struck down by the Supreme Court, while 33% said the justices will validate it.

While the Kaiser poll found that few Americans expect the high court's ruling to have a big impact on their lives, the lawsuit has garnered much attention from amicus brief filers – with about 140 friend-of-the-court briefs filed as of 16 March.

Meanwhile, the Obama administration is marking the two-year anniversary of the law this week by holding Q&A forums over Twitter, with White House officials providing responses to the public.

While the individual mandate does not kick in until 2014, several provisions of the law already have taken effect, including the requirement that children with pre-existing conditions be covered by insurers and that children are covered under their parents' health plans until they reach 26 years.

Insurers also can no longer impose lifetime limits on benefits and also must cover certain preventive services without deductibles or co-pays and the companies.

Among the most recent actions implemented under the law was the Obama administration's controversial rule requiring insurers to provide preventive services, including contraceptives without cost-sharing. After objections were raised last month, the administration revised its rule to permit nonprofit religious organizations not to pay for, provide or facilitate the provision of any contraceptive service they object to on religious grounds (scripintelligence, 13 February 2012, 5 March 2012).

On 16 March, the administration issued an advanced notice of proposed rulemaking outlining the draft proposals to implement that rule, opening up the proposal for public comment.

Administration officials that day also released a final rule governing student health plans.

In other Washington news:

Daiichi Sankyo leader recognized

As Washington celebrates the centennial anniversary of the 3,000 cherry trees bestowed by Japan on the District of Columbia in 1912 as a sign of goodwill, the US National Park Service (NPS) has acknowledged the "pivotal role" Dr Jokichi Takamine, the first president of what is now Tokyo-based Daiichi Sankyo, played in the gift a century ago with the installation of an information display on the Potomac River Tidal Basin near the Jefferson Memorial.

When Dr Takamine, a chemist who discovered adrenaline and takadiastase, heard that there was an effort in Washington to plant cherry trees, he donated the funds for 2,000 trees.

But when the cherry trees arrived in Washington in January 1910, an inspection by the US Department of Agriculture revealed the plants were infested with insects, and so were declared diseased and destroyed, according to the US NPS.

But Dr Takamine donated the funds for a new batch of trees to be shipped from Japan to Washington – this time increasing the number to just over 3,000 of 12 varieties of the cherry trees, with the first ones from the new lot planted on 27 March 1912.

Daiichi Sankyo is serving as the co-chair of the 2012 National Cherry Blossom Festival's Centennial Host Committee.

The cherry trees, which draw more than 1 million visitors each year during the festival, generally bloom in late March, but because of the warm winter, the blossoms arrived about two weeks early.

Will J&J pay more for Risperdal in DOJ deal?

Rumors swirled last week in Washington that the US Department of Justice (DOJ) decided to reject a $1 billion settlement with Johnson & Johnson, which was accused of illegal off-label promotion of its schizophrenia and bipolar drug Risperdal (risperidone) under an investigation that stems back to 2004 (scripintelligence, 16 May 2011).

DOJ is reportedly seeking a higher payment, possibly as much as $800 million more. But prosecutors were mum about those reports.

J&J in January settled with Texas as part of the broader case, agreeing to pay $158 million to resolve charges by prosecutors there that the company and its subsidiary Janssen had committed fraud against the state's Medicaid program by promoting off-label uses of Risperdal, specifically for use in children and the elderly (scripintelligence, 20 January 2012).

Endo amends Lidoderm petition

Endo Pharmaceuticals filed an amendment to its citizen petition with the US FDA calling on regulators to publicly address concerns raised by the Chadds Ford, Pennsylvania-based company and other experts about approval requirements for generic versions of its lidocaine patch, Lidoderm.

The firm said its amended petition highlights the "growing scientific and regulatory support" for requiring generic manufacturers to conduct comparative clinical endpoint studies to demonstrate bioequivalence to locally acting topical products like Lidoderm and also "raises several new issues that need to be resolved" before the FDA approves a generic version of the drug.

Endo Chief Scientific Officer Dr Ivan Gergel said that since the company filed its original citizen petition in 2006, new studies and opinions from research scientists, as well as public statements from FDA officials, have "further validated" the need for comparative clinical endpoint studies to ensure a locally acting topical medication is bioequivalent to the branded product.

"After more than five years of ongoing scientific discussion, there are no validated data to support using the level of lidocaine in the bloodstream as an appropriate method to demonstrate bioequivalence to Lidoderm," Dr Gergel said."All parties, including Endo, generic applicants, physicians, patients, and FDA will benefit from an open and transparent process for resolving the many scientific and legal questions."

FDA warns Warner Chilcott

Warner Chilcott disclosed on 13 March in a filing with the US Securities and Exchange Commission (SEC) that the US FDA warned the firm that it failed to conduct a comprehensive evaluation of its corrective actions for manufacturing violations at its Fajardo, Puerto Rico plant involving the firm's contraceptive Ovcon 50mcg (norethindrone/ethinyl estradiol).

In the 8 March warning letter, the FDA said that since 2006, seven of nine lots of Ovcon failed to meet the assay test specification for ethinyl estradiol at different stability testing intervals.

"We are concerned that the current stability data does not support your labeled expiration date," regulators said. "Significantly, your firm failed to identify the root cause of the problem and has been unable to implement appropriate corrective and preventive actions. In addition, during this same time period, your firm has continued to manufacture and release Ovcon 50 tablets, although these may be subpotent."

The FDA said that it was not until Warner Chilcott's recall initiated last summer of the Ovcon 50 tablets, which came as a result of the agency issuing a so-called Form 483 letter about the manufacturing problems identified, that the company performed a more rigorous evaluation of the manufacturing process and other possible root causes.

"Your quality unit failed to ensure that the drug product quality issues were adequately evaluated," regulators said.

Although Warner Chilcott instituted the recall of the affected lots of Ovcon 50 tablets, the FDA said it remains concerned about the quality problems that have gone unresolved for the last five years "without you fully understanding the reason for the failures and without assurance that the product will meet its quality attributes throughout the product's shelf life."

Regulators recommended the firm place all lots of Ovcon 50 on stability until it verifies that the company's corrective actions are effective.

The FDA asked Warner Chilcott to provide its plan to the agency for ensuring other products the firm manufactures will meet the required specifications through their expiration dates.

"The company takes these matters seriously and intends to respond fully to the FDA's requests within the required time frame," Warner Chilcott stated in its SEC filing.

Following the receipt of the Form 483 observation letter, Warner Chilcott asserted that it "immediately" initiated efforts to address the issues identified by the FDA and has been "working diligently" to resolve the agency's concerns.

The company noted that until the cited issues are resolved, the FDA may withhold approval of requests for pending drug applications listing the Fajardo facility, among other things.

Warner Chilcott insisted that it does not expect its ability to manufacture or ship any of its current material products from its Fajardo facility would be impacted. Nonetheless, the firm said it could give no assurances that the FDA would be satisfied with the company’s response to the warning letter or to the expected date of the resolution of the matters included in the warning letter.

This and past US Capitol Capsule columns are available at http://www.scripintelligence.com/capitolcapsule/