Jill Wechsler, Pharm Exec’s Washington Correspondent

Patient advocates recently surprised pharmacists and manufacturers by convincing an FDA advisory panel to recommend increased government scrutiny of its voluntary patient information policy. FDA's Drug Safety and Risk Management Advisory Committee met in July to review the status of a private sector initiative for distributing medication information to patients obtaining prescriptions in pharmacies.

The House leadership collected just enough votes in late June to approve a Medicare reform bill that provides some coverage of pharmaceuticals for seniors. Democrats rebuked the measure as a scam and a fraud; some conservatives complained that it opened the door to a costly new entitlement.

In case anyone missed the recent wave of studies and reports documenting rising expenditures on medicines, Families USA weighed in with an analysis that further documents rising prices of medicines prescribed for the elderly. The report surfaced just before the US House of Representatives voted on a Medicare pharmacy benefit and was timed to influence that debate.

In a closely watched patent case that has important implications for pharma companies, the Supreme Court ruled unanimously in May to uphold policies that protect patent holders from imitators. The decision, in what is considered one of the most significant patent disputes to come before the court, is expected to benefit brand-name companies that bring patent infringement cases against generics makers.

As part of an aggressive campaign against the rising cost of medicines, AARP, the national advocacy group for Americans over 50, joined three class-action lawsuits against pharma companies involving alleged anticompetitive efforts to block generic competition and inflate prices.

Just before the Memorial Day recess, Congress approved legislation to enhance public health agencies' ability to respond to bioterrorist threats. A key addition to the bill reauthorizes the Prescription Drug User Fee Act (PDUFA) for five years. The revised program significantly increases companies' fees to support expanded FDA operations, gives the agency more flexibility in using fee revenues, and backs new initiatives to streamline the drug development and approval process.

Does FDA harm patients by rushing unsafe products to market or by slowing product development and approval? That debate came to the fore recently with the almost simultaneous release of competing studies.

First Amendment protection of commercial speech got a big boost last month when the US Supreme Court ruled 5-4 that FDA's policy to limit advertising for pharmaceutical compounding is unconstitutional.

One of the Hatch-Waxman Act's authors opposes proposed changes to the 1984 legislation.

The National Institute of Health Care Management made headlines with its report on double-digit increases (17 percent) in retail spending on medicines in 2001. The total reached $155 billion last year, almost double the $80 billion spent in 1997, according to the study, "Another Year of Escalating Costs." PhRMA president Alan Holmer said the increase is a good thing, signifying that more people who need medicines for chronic conditions are being treated and thereby avoiding more expensive medical procedures.

African-American physicians regard direct-to-consumer advertising of prescription medicines as one way to educate minority patients about needed treatment and healthcare options, according to a survey conducted by the National Medical Association (NMA). Almost all of the 900 physicians answering the questionnaire reported that DTC advertising has prompted patients to ask questions, and one-third acknowledged that they feel additional pressure to justify their prescribing decisions. But almost half (48 percent) said that such promotion increased communications between physicians and patients.

Among the dozens of initiatives in Washington affecting the pharma industry, one common thread is the growing movement to control accelerating expenditures for prescription medicines.

Washington DC-In addition to launching an ad campaign backing adoption of a Medicare drug benefit, PhRMA is expanding its state lobbying efforts to block local prior authorization requirements. As more states face huge shortfalls in Medicaid budgets because of declining revenues and rising healthcare costs, they seek to cut spending on prescriptions. That means more restricted formularies and rebate requirements, with prior authorization imposed on doctors to limit prescribing of therapies that fail to offer sufficiently attractive deals.

After months of stalemate between the White House and Senate democrats over the appointment of a new FDA commissioner, Health and Human Services secretary Tommy Thompson took a shortcut February 26 and named Lester Crawford deputy commissioner. The move allowed Crawford to start work at FDA immediately, skipping the lengthy Senate confirmation process.

Eli Lilly recently joined the growing list of pharma companies offering discount card programs for Medicare beneficiaries in an effort to "do something now" to help low-income seniors afford medicines. Although Lilly chairman Sidney Taurel voiced support for a broader drug benefit for the elderly-as do his pharma colleagues-he described the LillyAnswers program as "quick relief" while the Medicare-reform debate continues.

As proposals proliferate to establish a Medicare pharmacy benefit, the cost estimates continue to soar. The White House began in February by proposing to spend a measly $190 billion over ten years.

Washington DC-As part of its continuing investigation into competition and intellectual property rights, the US Federal Trade Commission and the Antitrust Division of the Department of Justice recently kicked off a series of hearings.

Even though FDA officials and company executives maintain that Purdue Pharma hasn't violated any rules governing pharma advertising, critics who want to ban the sale of the painkiller OxyContin complain about the company's promotional excesses. At a hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee in February, patient advocates blamed soaring abuse of the medication on company sales and advertising activities.

The spread of counterfeit products around the world has alarmed companies and international agencies and prompted them to accelerate efforts to address the problem

Washington, DC-Pro-life advocates recently dropped a lawsuit challenging the promotion of abortifacient RU-486 through ads sponsored by the National Abortion Federation. The suit charged NAF with using deceptive advertising by promoting Mifepristone as safe in several national magazines, including Self, Cosmopolitan, InStyle, Vanity Fair, and People. The ads stated, "You have the freedom to choose. And now, you have another safe abortion choice."

Healthcare costs and health insurance premiums have soared, and analysts point to double-digit hikes in spending on prescription medicines as a prime culprit. A recent annual survey by the Department of Health and Human Services' (HHS) Centers for Medicare and Medicaid Services (CMS) finds that healthcare spending in 2000 increased 7 percent to $1.3 trillion, the biggest increase in the past decade, outpacing gross domestic product growth. Prescription drug expenditures alone jumped 17 percent, making them the fastest growing service expense for that year. The Kaiser Family Foundation (KFF) also reports that the portion of total healthcare spending devoted to

Washington, DC-A new advisory committee appointed by HHS secretary Tommy Thompson will scrutinize agency policies to identify ways to improve programs and regulations.

The main challenge for pharma companies this year will be to address public concerns about drug prices and access. Although recent bioterrorism fears raised demands for life-saving medicines, the public focus has shifted to the rise in pharmaceutical expenditures and its effect on healthcare costs and on efforts by insurers and government health agencies to limit pharmaceutical coverage.

One reason new medicines are more expensive is that the cost of discovering and producing new therapies is soaring.

The wrangling over whether pharma companies invest more in R&D than in marketing is heating up again.

If you support the pharmaceutical industry, you will applaud Alan Holmer and the Pharmaceutical Research and Manufacturers of America he presides over. You might disagree with some of the details. But mud you will not sling, nor buy every critic's case against this protector of the industry.

Washington, DC-With no signs that FDA plans to significantly limit direct-to-consumer advertising of prescription medicines, state governments across the country are proposing their own curbs. During the past year, legislators considered some 60 bills or resolutions concerning pharma marketing or advertising, and efforts are likely to increase as state policy makers link DTC advertising to rising drug expenditures.

Washington, DC-The run on Cipro following October's anthrax scare was a bonanza for pharmacy websites, but it stirred the wrath of both FDA and the medical establishment. In response to escalating ciprofloxacin promotion over the internet, FDA sent cyber letters to 11 websites for offering US consumers products that may not be approved for sale in the United States, warning that US Customs might detain shipments. The agency also took more stringent action against five previously warned foreign vendors.

Washington, DC-Pharma companies suffered a significant setback last month when developing countries at the World Trade Organization meeting pushed through a declaration allowing nations to override patent laws to cope with health crises. Although industry officials insisted that the agreement would have little impact on profits, the language sets the stage for more competition from cheap generic products in much of the world.

Washington, DC-To improve FDA's ability to respond to terrorist attacks, acting commissioner Bernard Schwetz tapped Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), to establish a formal crisis management program for the agency. Woodcock moved to the commissioner's office in November to develop a program to better track and coordinate FDA responses to terrorism.