Legislative News — Chain Pharmacy, 6/25/12
WASHINGTON — Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.
News media reported last month that the bills, sponsored by Rep. Tim Murphy, R-Pa., would create an expedited FDA approval pathway for follow-on versions of biogenetic medications, such as vaccines and drugs made from human tissue and plasma. According to media reports, Murphy said the legislation would make the medications more affordable and accessible while ensuring that offshore drug makers are held to the same manufacturing standards as those based in the United States.
According to reports, the House Energy and Commerce Committee voted 46-0 to send the bill to the House floor.
MONTGOMERY, Ala. — A new law in Alabama will establish standards in the pharmacy audit process conducted by pharmacy benefit managers in the state. Last month, Alabama Gov. Robert Bentley signed SB 383, the Pharmacy Audit Integrity Act, which establishes uniform standards for the auditing of pharmacy records and includes requiring two weeks written notice of an audit. The law also requires audits that involve clinical or professional judgment be conducted in consultation with a pharmacist and establishes an appeals process.
The bill drew praise from the National Association of Chain Drug Stores, which has endorsed federal legislation that seeks to preserve pharmacy choice for patients and takes additional steps to prevent threats to pharmacy patient care. The bipartisan Pharmacy Competition and Consumer Choice Act — S. 1058 and H.R. 1971, sponsored by Sen. Mark Pryor, D-Ark., and Rep. Cathy McMorris Rodgers, R-Wash., respectively — includes provisions requiring transparency by PBMs in pharmacy audits.
MONTPELIER, Vt. — Vermont also enacted a PBM audit law, which drew praise from NACDS as well. S. 200, signed into law by Vermont Gov. Peter Shumlin, establishes consistent standards for the auditing of pharmacy records and includes requiring two weeks written notice of an audit; requires auditing records be provided to the pharmacy; sets a 60-day deadline for the preliminary audit report following completion of an audit; and establishes a written appeals process.
“We thank Gov. Shumlin for enacting this important pro-patient, pro-pharmacy legislation to curb practices used by some PBMs that jeopardize the role of community pharmacy in improving patient care and making healthcare delivery more efficient and cost-effective,” NACDS president and CEO Steve Anderson said. “We thank the Vermont Association of Chain Drug Stores for their leadership in helping to ensure transparency in the PBM audit process.”
PDUFA reauthorization moves toward resolution
Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval.
On May 24, the Senate voted 96-1 to approve the reauthorization and modification of the user fee program, with Vermont independent Sen. Bernie Sanders casting the sole dissenting vote with the assertion that it wouldn’t do enough to bring down drug prices. The House followed suit, overwhelmingly approving its own version of PDUFA legislation May 30.
Both versions include new provisions that would create, for the first time, a user fee program for generic drug makers. The generic industry would pay $299 million a year in user fees for the next five years — beginning Oct. 1, 2012 — for new FDA staff, faster generic approvals that could help clear a backlog of some 2,500 applications and more inspections of manufacturers’ production plants.
In another key change, the PDUFA proposals would create a user fee program for makers of biosimilar drugs.
The House and Senate must still hammer out any differences in legislation. Some members of Congress predict that will happen before the July 4 recess.
Both the branded and generic drug industries hailed the moves in Congress. Ralph Neas, president and CEO of the Generic Pharmaceutical Association, said they’ll move Americans “one step closer to receiving faster access to … generic medicines.”
Said John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, “by casting a positive vote to reauthorize PDUFA, members of both the House and the Senate … have acted in the best interests of America’s patients.” The new funding, he added, also will “provide the FDA with the resources necessary to help build new scientific and regulatory capabilities … and promote ongoing biopharmaceutical innovation.”
One provision of the Senate’s version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, did raise alarm bells among pharmacy groups, however. Five organizations — including the American Pharmacists Association, National Association of Chain Drug Stores and National Community Pharmacists Association — registered opposition to an amendment by Sen. Joe Manchin, D-W.Va.
Manchin’s proposal would make it tougher for patients to obtain common pain relief remedies containing hydrocodone by raising them from schedule III to the more restrictive schedule II classification. The change would “result in significant barriers for patients who have a legitimate need for these products, and it will result in adding to the nation’s healthcare costs with no assurance of a reduction in diversion and abuse,” the pharmacy groups warned.
Study: Mobile reminders improve adherence
Medication adherence rates are higher among patients who receive text message prescription reminders than among those who don’t, according to a new study. The study — conducted by OptumRx, part of UnitedHealth Group, and published in the May issue of the journal Clinical Therapeutics — found that patients taking chronic oral medications showed higher medication adherence if they took part in a text message prescription reminder program offered through OptumRx’s pharmacy benefit management organization. The company said this was the first large-scale study in the United States to determine if a text message program providing medication-specific reminders could increase adherence. Previous studies included smaller patient pools, often with fewer than 100 patients, and were focused on homogenous patient groups, such as those being treated for the same disease.
“Text messages and emerging technologies offer new opportunities to educate and engage patients so they can improve their health and ultimately rein in their healthcare costs,” OptumRx pharmacist and lead author Kalee Foreman said. “A study in the New England Journal of Medicine found that nearly 70% of medication-related hospital admissions in the United States are due to poor medication adherence, costing the healthcare system roughly $100 billion per year.”
The study, which enrolled 580 members of employer-sponsored Medicare programs, found that patients who received text message reminders had adherence rates of 85%, compared with 77% of those who did not receive the reminders. Among patients who had diabetes, adherence rates were even higher, with a rate of 91% among those who received reminders and 82% among those who didn’t.
Among patients taking beta blockers, similar rates were observed, with 88% adherence among those receiving messages and 71% among the control group. The study measured adherence by “proportion of days covered,” or PDC, which examined each day between Jan. 1, 2011, and Aug. 1, 2011, to determine if the patient had the drug on hand.
“This research provides strong evidence that technology can play a vital role in improving medication adherence, even among older patients,” OptumRx chief medical officer Brian Solow said. “This is of great importance to all stakeholders in health care because poor medication adherence can lead to inferior treatment outcomes, higher hospitalization rates and increased healthcare costs.”