NCPA among industry associations rejecting proposal to reschedule hydrocodone
ALEXANDRIA, Va. — The National Community Pharmacists Association last week called for the rejection of a proposal made by Sens. Joe Manchin, D-W.Va., and Mark Kirk, R.-Ill., to reschedule Vicodin and other hydrocodone-containing products from Schedule III to Schedule II of the Controlled Substances Act.
"Community pharmacists share concerns regarding the abuse and diversion of prescription drugs. Abuse of these drugs can ruin lives, devastate families and has contributed to dangerous crimes against pharmacies," stated NCPA CEO Douglas Hoey. "Aggressive anti-drug abuse efforts must be balanced with preserving legitimate patient access to necessary prescription drugs. This legislation, while well-intentioned, fails that test," he said. "It would create significant hardships for many and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care settings. Moreover, there are far more practical means available by which Congress and law enforcement can reduce prescription drug abuse without inflicting collateral damage on many innocent patients and the pharmacists caring for them."
Nearly 3,000 different combinations of strength, formulation and manufacturer of hydrocodone-containing products exist. Moving them to the more restrictive Schedule II could significantly delay patient access by eliminating phoned-in prescriptions, stopping prescription refills and, in some cases, prohibiting electronic prescribing. Higher healthcare costs would almost certainly result in order to account for increased physician interactions and other administrative burdens associated with Schedule II medications.
A group of patient and pharmacy groups including NCPA recently sent a letter to the Food and Drug Administration raising many of the same points. The letter was signed by American Academy of Pain Management, American Association of Nurse Assessment Coordination, American Cancer Society Cancer Action Network, American Society of Consultant Pharmacists, Amputee Coalition, CarsonCompany, Citizen Advocacy Center, Interstitial Cystitis Association, Long Term Care Pharmacy Alliance, Massachusetts Pain Initiative, NADONA, National Association of Chain Drug Stores, National Fibromyalgia & Chronic Pain Association, National Hospice and Palliative Care Organization, Pain Treatment Topics, US Pain Foundation and the Wisconsin Pain Initiative.
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Kentucky enacts MAC reform
FRANKFORT, Ky. — Kentucky on Friday became the first state to enact legislation that provides pharmacists with transparency into how health plans determine pharmacy reimbursements for generic drugs, and establishes an appeals process when a dispute arises over those payment levels.
Specifically, the new law creates a set of standards with relation to categorizations and formularies for how pharmacy benefit managers craft their MAC lists, requires more frequent updates and streamlines the process for pharmacy reimbursement appeals.
"This transparency legislation will simply let pharmacists know how individual health plans will calculate a pharmacy’s reimbursement, and require timely updates to those rates to reflect market prices," noted Douglas Hoey, CEO for the National Community Pharmacists Association, which had lobbied for the bill. "With that information a small business community pharmacy owner can better evaluate contract proposals and determine whether they make business sense to accept. That, in turn, will benefit Kentucky patients and the state’s economy," he said.
"We hope Kentucky’s common-sense MAC reform serves as a model for the nation as similar legislation is being considered across the country, Hoey concluded"
Supreme Court hears patent-settlement case
NEW YORK — The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.
The case, Federal Trade Commission v. Actavis, marks the latest attempt by federal authorities to put an end to what they say are deals between branded and generic drug companies that delay release of generic drugs to consumers.
The case centers on a common practice in which a generic drug company that wishes to market a version of a branded drug before its patent expires files an approval application with the Food and Drug Administration containing a Paragraph IV certification, a legal assertion that the patent is invalid, unenforceable or won’t be infringed. In response, the branded drug company will generally file a patent-infringement lawsuit to stop the FDA from approving the drug. The companies will often reach a settlement that ultimately allows the generic drug company to launch well before patent expiration, and under current laws, a generic version must be launched by the time the patent expires anyway.
For the FTC, as well as many members of Congress and consumer groups, the issue is when the generic drug company agrees to hold off launching the drug in exchange for some type of consideration from the branded drug company, such as monetary payment or an agreement by the latter not to launch a cheaper version of the drug through a third-party company, also known as an authorized generic. Opponents of such deals call them "pay-for-delay" settlements and contend that they keep drugs out of the hands of consumers for longer than if no settlement had taken place.
"If there’s money on the table, the generic firm will accept a later entry date," David Balto, former FTC policy director under the Clinton administration, who filed an amicus brief with the court in support of the FTC’s position, told Drug Store News. "If there’s no money on the table, the generic firm will bargain for the earliest possible entry date."
Balto expressed optimism for the FTC side, saying that the court appeared highly skeptical of the generic drug industry’s position. "Ultimately, this will be very good for consumers because the FTC’s position will get generic drugs into the hands of consumers faster," Balto said.
Meanwhile, the Generic Pharmaceutical Association (GPhA) contends that the settlements are ultimately pro-consumer because they get generic drugs to the market months or years ahead of patent expiry. The group points to a 2010 study by the Royal Bank of Canada of 370 patent-litigation suits, which found that when the suits went to trial, the generic drug industry prevailed 48% of the time, compared with 76% of the time when litigation was settled.
"The FTC’s case is built on a house of cards," GPhA president and CEO Ralph Neas said in a conference call with reporters Monday, saying the agency’s position relied on "assumptions and methodologies that are false" and based on a study more than 10 years old.
"We believe the FTC’s position, if upheld by the court, would harm consumers," Actavis president and CEO and former GPhA chairman Paul Bisaro said in the call.
In the Senate, a bill is under consideration that would also seek to restrict patent settlements between branded and generic drug companies. In a recent white paper, former Clinton administration solicitor general Paul Bender called the bill, S. 214, "hopelessly flawed," saying it would interfere with litigant rights to settle, create unfair burdens of proof, conflict with the statutory presumption of patent validity, frustrate provisions in the Hatch-Waxman Act of 1984 that favor litigation and preclude settlements.
"Rather than adopting that unusual and dangerous solution, the government should utilize the tools it has in hand under the Medicare Modernization Act of 2003 that require the FTC to review and prove the illegality of settlements on a case-by-case basis," Bender wrote.