News and Trends

AUGUST 10, 2011

Drug Approvals on Pace to Exceed 2010 Total
The FDA has approved 20 new drugs so far this year, just 1 short of the total for all of 2010, putting the agency on track to approve more new types of drugs in 2011 than in the previous few years.

In testimony before the House Energy and Commerce Committe’s health subcommittee, Janet Woodcock, MD, head of the FDA’s drug division, responded to lawmakers’ concerns that a tougher safety stance taken by the agency was slowing the pace of drug approvals. Dr. Woodcock explained that more than 90% of deadlines that are part of the drug review process are met by the FDA, according to The Wall Street Journal. She also noted that first-cycle approvals are at a 20-year high, and that more than two-thirds of new drugs are being approved within the allotted 6-to-10-month time frames. Some of the notable approvals in 2011 include 2 new hepatitis C drugs and the melanoma treatment Yervoy (ipilimumab).

The new drug approval list also includes products that were initially delayed, including Benlysta (belimumab), a lupus treatment, and Xarelto (rivaroxaban), a drug that was approved to prevent blood clots after a 2-year delay.

Jonathan Leff, a managing director at Warburg Pincus LLC, a private equity and venture capital firm, said the FDA’s tougher focus on drug safety since the 2004 market withdrawal of the painkiller Vioxx (rofecoxib) is a major contributor to the rising cost and length of drug development.

“At a time when medical research is exploding with potential, many promising scientific discoveries are not being developed into new treatments for disease due to lack of investment capital,” Leff said.

Medicare Patients Get Drug Discounts through Affordable Care Act
Nearly 480,000 Medicare Part D recipients saved more than $260 million in the first 5 months of 2011 as a result of the health care reform law’s provision to gradually close the coverage gap known as the “doughnut hole,” according to the Centers for Medicare & Medicaid Services (CMS).

The agency predicted that an additional 4 million patients would fall into the doughnut hole this year and become eligible for the savings, which have averaged around $545 per beneficiary. In May alone, the total number of individuals who received the discount rose by more than 76%, and the dollar amount of savings increased by more than 56%.

Most of the discounts are being used to help manage serious medical conditions. According to CMS, nearly 14% of the benefits provided are used for cancer drugs, more than 8% are for medications that control high blood pressure and cholesterol, and more than 7% are for diabetes drugs.

“Without the Affordable Care Act, many seniors and people with disabilities would pay twice as much for their prescription drugs in the doughnut hole,” said CMS Administrator Donald M. Berwick, MD. “People on Medicare will now be able to better afford their medicine, and these discounts will continue as coverage in the gap grows until the doughnut hole is closed.”

AMA to Evaluate the Evolving Role of Pharmacists
The American Medical Association (AMA) is taking a new look at the role of the pharmacist on the health care team.

At the annual meeting held in Chicago, Illinois, in June 2011, the AMA House of Delegates adopted a resolution to “develop model state legislation to address the expansion of pharmacist scope of practice that is found to be inappropriate or constitutes the practice of medicine.”

The adopted language was scaled down considerably in tone and rhetoric from 2 original resolutions after a consortium of 10 pharmacy organizations led by the American Pharmacists Association (APhA) presented information about the pharmacist’s role in providing patient care.

“It will be beneficial for both professions and especially for our patients if medicine and pharmacy work together to address the issues brought up in the House,” said Anne Burns, senior vice president of professional affairs at APhA.

In comments filed with the Reference Committee, APhA said the resolutions were “inconsistent with the existing scope of pharmacy practice recognized in all 50 states and could undermine efforts that foster the kind of coordination of care among individual and institutional providers that will improve the quality and delivery of care.”

The Reference Committee responded by making changes to the resolution. The amended language was adopted by the House of Delegates without further change.

“We plan to work with AMA as they implement this policy and work on principles relevant to the scope of pharmacy practice,” said Marcie Bough, PharmD, senior director of government affairs. “We have long had a good working relationship with AMA, and we are certain that these policies will provide an opportunity to network with our colleagues in medicine and serve as a resource for them on the evolving role of pharmacists in teambased approaches to patient care.”

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