Improvita private-label item gets retailers in hot water
NEW YORK It’s a reminder that retailers are only one step removed from litigations involving one of their suppliers, especially when that supplier is manufacturing a store brand offering for them.
But perhaps more important, it may also be an indicator that like the Food and Drug Administration, the Federal Trade Commission may be a little more proactive in pursuing regulatory actions than they may have under the Bush administration. The FDA so far this year has issued more than 60 warning letters to dietary supplement companies making inappropriate treatment or prevention claims, and that’s just since the inauguration. It’s not as though the regulation isn’t clear — supplement companies cannot make claims that their products cure, mitigate or prevent any disease state. Though to be clear, many of the recent warning letters target online-only supplement distributors making such egregious claims as cancer prevention or a swine flu cure.
Dietary supplement manufacturers have already done quite a bit to shed an underserved reputation of shilling snake-oil-type products. The Council for Responsible Nutrition, for example, has funded increased advertising review by the National Advertising Division, a program that’s expected to receive additional funding going forward. The association has also become more aggressive of late in defending the industry by challenging critical news reports that base their criticisms on inaccuracies or faulty meta-analyses, and counter those criticisms with arguments grounded in science.
Senate panel votes in favor of healthcare reform bill
NEW YORK After decades of fruitless efforts, activist lawmakers in a Democratically controlled Congress finally may be on the verge of pushing through one of the most elusive policy goals of the past half-century: a massive reform of the U.S. healthcare system that aims to extend health coverage to most Americans and put a clamp on federal healthcare spending.
That bill, the Affordable Health Care Choice Act of 2009, is a long way from passage. Republicans on the Senate HELP Committee object to several key provisions in the bill – including language that would impose higher taxes on the wealthiest Americans to help pay the bill’s estimated trillion-dollar 10-year tab, a new government-run insurance provider to compete with private-sector insurers and a provision that would penalize employers who don’t offer health benefits to their workers – and that opposition is sure to play out when the House of Representatives and the full Senate debate the measure in coming days.
Nevertheless, even staunch conservative lawmakers acknowledged that the climate for health reform is ripe. Spurred by public alarm over the rising cost of health care and dire projections about the future of Medicare and Medicaid, the Obama administration and the President’s allies in Congress have made overhauling the healthcare system a top legislative priority, and are pushing for fast-track passage of a bill before the end of the current session.
It’s too soon to tell just what impact the bill would have on some of the biggest issues of concern to retail pharmacy, such as Medicaid reimbursement. But concerns over costs and employer mandates aside, chain and independent pharmacy advocates have found much to like in the Affordable Health Care Choice Act.
As envisioned by HELP Committee chairman Sen. Edward Kennedy, the bill, if passed in its current form, would advance the concept of pharmacy care, elevate the role of pharmacists as patient-focused community health practitioners and exempt retail pharmacies from accreditation requirements for the sale of durable medical equipment, a cause long sought by pharmacy leaders.
Needless to say, the bill also would swell the roles of prescription drug customers by expanding affordable coverage to most of the estimated 45 million to 50 million uninsured Americans.
Among the pharmacy-friendly provisions championed by Kennedy and other supporters of the bill:
- The establishment of community health teams to set up the “medical home” model of individualized health care for patients – a model that could include retail pharmacies as “homes;”
- Funding of a pioneering grant program to implement medication therapy management for the treatment of chronic diseases;
- Greater incentives to spur generic drug switching and the adoption of health information technology;
- A greater emphasis on disease prevention through healthier lifestyle and nutrition, and closer coordination between health counselors (including pharmacists, presumably) and patients; and
- The creation of an approval pathway for biogenerics at the Food and Drug Administration.
EU approves Pfizer’s pending acquisition of Wyeth
NEW YORK Pfizer on Friday announced that the European Commission has approved under the European Union Merger Regulation the company’s pending acquisition of Wyeth. The commission’s decision includes Pfizer’s commitment to divest certain animal health assets in the European Union.
“We are pleased to have achieved another significant milestone for the pending acquisition with the EC’s approval of the transaction,” stated Amy Schulman, SVP and general counsel of Pfizer.
In addition, Pfizer announced that China’s Ministry of Commerce has extended its review of Pfizer’s regulatory submission beyond the initial thirty-day period. The completion of the transaction remains subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, governmental and regulatory approvals in certain other jurisdictions, and approval by the stockholders of Wyeth.
“We continue to work cooperatively with the regulatory agencies to obtain the requisite approvals, and continue to expect the transaction to close at the end of the third quarter or during the fourth quarter of 2009,” Schulman said.