Medical Devices and Prescription Drug Policy

House Democrats are asking the head of Johnson & Johnson to testify later this month over the April recall of 135 million bottles of infant and children's medicine.

The House Oversight and Government Reform Committee, headed by Rep. Edolphus Towns (D-N.Y.), also wants J&J CEO William Weldon to respond to new information gathered during the panel's ongoing investigation into charges the company hired private contractors in 2008 to go store to store and buy up defective Motrin tablets — an episode Towns has dubbed the "phantom recall."

Towns on Thursday released e-mails from one of those contractors — San Diego-based WIS International — suggesting the company planned to extend the phantom recall to other defective products.

"[W]e are exploring another similar but potentially larger recall for July involving Children's Tylenol," a WIS executive wrote in June 2009. The effort, the executive continued, "would make our Motrin project look small."

J&J launched an enormous recall of a number of its products, including Motrin and Children's Tylenol, in April of this year.

That timeline, combined with the new e-mails, raises two important questions, Towns says.

"First, was Johnson & Johnson considering conducting a phantom recall of children's medicine?" Towns wrote Thursday in a letter to Weldon. And second: "Was Johnson & Johnson aware of problems with Children's Tylenol and other children's medicines months before it actually recalled these products?"

The hearing is scheduled for Sept. 30.

Children's cancer advocates pressed lawmakers to pass several pieces of legislation during a Congressional Childhood Cancer Summit Thursday.

The legislation includes:

• Reauthorization of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, which would allow for the creation of incentives for manufacturers to develop drugs to treat children's cancer. Although 12,500 children are diagnosed with cancer every year, that's only 1 percent of the national total, making pediatric drug research largely unprofitable;

• The Create Hope Act, which would provide incentives for biotechnology and pharmaceutical companies to develop drugs for pediatric cancers and other pediatric rare diseases through a priority review voucher program. The bill was introduced by Sens. Sam Brownback (R-Kan.) and Sherrod Brown (D-Ohio); and

• The Childhood Cancer Survivorship Research and Quality of Life Act, which proposes new research on how to improve follow-up care and create systemic interventions to improve children's quality of life. The bill was introduced by Reps. Jackie Speier (D-Calif.) and Mary Bono Mack (R-Calif.)

Thursday's summit was convened by Reps. Michael McCaul (R-Texas) and Joe Sestak (D-Pa.), co-chairs of the Congressional Pediatric Cancer Caucus.

An insurance giant has signed on as the newest member of Washington's leading pharmaceutical benefit manager (PBM) lobbyist group.

Wellpoint, Inc., the Indianapolis-based insurer, will join the Pharmaceutical Care Management Association (PCMA), the groups announced Thursday.

"WellPoint has a unique role in the insurance market as the nation’s largest healthcare benefits company that also continues to maintain control over our formulary and clinical programs," Pete Clagett, a WellPoint vice president, said in a statement. "We look forward to working with PCMA to communicate with the news media, policymakers, and others the integral role PBMs play in lowering costs and enhancing access for consumers and payers."

PBMs act as middlemen, negotiating prices and processing claims between pharmacists, insurers and drug makers. The industry has been under the microscope in recent years over allegations that some PBMs overcharged for drugs and that others sought kickbacks from drug makers to favor their products.

In response, the new health reform bill requires PBMs operating under Medicare or exchange plans to disclose details about its price negotiations to the Health and Human Services Department. 

Mark Merritt, president and CEO of PCMA, welcomed the addition of Wellpoint on Thursday, saying the PBM model provides "workable prescription drug solutions for policymakers seeing to balance cost and access."

This post was updated at 5:30 p.m.

Reps. Michael McCaul (R-Texas) and Joe Sestak (D-Pa.) are hosting a panel of the nation's top cancer doctors next week for a Congressional Childhood Cancer Summit.

The Sept. 16 summit, to coincide with Childhood Cancer Awareness Week, is expected to address issues such as drug development, availability of treatment, access to clinical trials, survivorship and the impact of childhood cancer on families and communities. It also seeks to draw attention to several pieces of legislation currently stuck in Congress. 

Rep. Jackie Speier's (D-Calif.) Childhood Cancer Survivorship Research and Quality of Life Act creates National Institutes of Health grants to research cancer survivorship and improve follow-up care. And Sen. Sam Brownback's (R-Kan.) Creating Hope Act would reform the Food and Drug Administration's priority review voucher incentive program relating to tropical and rare pediatric diseases.

McCaul and Sestak are the founders and co-chairs of the Congressional Pediatric Cancer Caucus.

Genzyme Corp. this week snubbed an $18.5 billion buyout bid by Sanofi-Aventis, arguing that the offer grossly undervalues the Cambridge, Mass.-based biotech company — one of the largest in the world.

“The Genzyme board is not prepared to engage in merger negotiations with Sanofi based upon an opportunistic proposal with an unrealistic starting price that dramatically undervalues our company," Genzyme CEO Henri Termeer wrote to Sanofi Monday.

The $18.5 billion offer breaks down to about $69 per share. Citibank analysts estimate that Sanofi-Aventis would have to hike its offer to as high as $77 per share to entice Genzyme shareholders to support the deal, Bloomberg reported Tuesday. 

New rules surrounding Medicare's prescription drug benefit could force more than 3 million seniors to adopt different plans next year, according to an analysis by a leading healthcare group.

Republican critics of healthcare reform are already pointing to the report as evidence that the White House was disingenuous in its claims — heard often during the health reform debate — that consumers who like their plans can keep them.

At issue are new "meaningful differences" rules issued in April by the Centers for Medicare and Medicaid Services (CMS). Next year, under those guidelines, CMS will accept Part D bids only for plans that differ dramatically from other plans offered by the same company. 

As a result, "many Part D sponsors will have to reduce their plan offerings and potentially make changes to the benefit package and cost sharing in order to meet the new requirements and continue to offer multiple plan offerings," according to analysts at Avalere Health, a Washington-based healthcare consultant group.

Specifically, the group estimates:

• About 2.75 million seniors in basic Part D plans will have to choose a new plan next year because the new rules prevent sponsoring companies from offering more than one basic plan in any one region.

• About 350,000 seniors in enhanced Part D plans without gap coverage will be forced to shift into new enhanced plans — the result of new rules limiting companies to two enhanced plans per region.  

• An additional 645,000 beneficiaries in enhanced plans with some 2010 gap coverage "may" have to choose new plans in 2011, "depending on whether or not those enhanced plans meet the CMS definition of 'meaningfully different,'" Avalere writes.

The group was quick to note that its figures are approximate estimates, given that analysts didn't have access either to details about 2010 out-of-pocket costs or to information about 2011 plan offerings. 

"Given those limitations," Avalere said, "our estimates represent a conservative approximation of the potential impact of plan changes to meet the new requirements on beneficiaries." 

Still, the office of Rep. Dave Camp (Mich.), senior Republican on the Ways and Means Committee, shot out the analysis to reporters Wednesday.

Avalere's figures were based on an examination of Part D beneficiaries who, as of last February, were enrolled in standalone plans offered by the top 10 Part D sponsors.

Prescription drug prices for seniors jumped more than 8 percent last year — the steepest increase in the last six years, according to an analysis by AARP released Wednesday.

The cost of every one of the 25 most popular branded drugs among Medicare patients rose higher than inflation in 2009, according to AARP, the 50+ lobby. Of the 217 best-selling branded prescriptions among seniors, the group found, 211 saw retail price hikes exceeding general inflation.

On average, the retail price of those 217 drugs rose 8.3 percent last year — higher than the jump in any of the previous five years, which ranged from 6.0 percent to 7.9 percent, AARP said.  

“These are increases that hit the wallets of every American, whether through their own health care bills or the costs of programs like Medicare and Medicaid,” John Rother, AARP's executive vice president, said Wednesday in a statement.

AARP has long followed the cost trends in the prescription drug market, but this year's analysis marks the first time the group has focused on retail prices for consumers, rather than the cost to manufacturers to produce the drugs. 

The drug lobby has criticized past analyses, saying the manufacturers' price doesn't take into account the rebates the companies give to seniors at the drug counter. It won't be able to make the same argument this year, Rother said.

“For the first time, we know that brand name drug retail prices are growing just as quickly as manufacturer prices,” he said.

Among the notable price hikes, the cost of Flomax (0.4 mg capsules), the prostate drug, jumped 24.8 percent in 2009; Provigil (200 mg), which treats sleeping disorders, jumped 22.7 percent; and Prevacid (30 mg), a popular antacid, leapt 23.1 percent. 

"Unless something is done to bring down their skyrocketing price increases, life-saving medicines will be out of reach for too many.  The health care law made some progress by closing the Medicare doughnut hole, but Congress and the industry must bring more competition and transparency to the marketplace."

The pharmaceutical industry perennial ranks among the most profitable in the country. In 2008, instance, Forbes, drug companies reported profits of 19.3 percent relative to revenues — third highest among all industries, Forbes found. 

The Food and Drug Administration's approval on Friday of the emergency contraceptive Ulipristal — also known under the brand name ella — drew swift disapproval from Americans United for Life.

The drug, already sold in Europe, can prevent pregnancies up to five days after sex. Anti-abortion groups argue the drug causes abortions.

"The FDA's irresponsible approval of ella (Ulipristal), without adequate safety studies, places women's health and lives at risk," said Charmaine Yoest, President and CEO of Americans United for Life. "Furthermore, billing this abortion-causing drug as an 'emergency contraceptive' is misleading to the public."

Americans United for Life is part of a coalition, ella Causes Abortions, that signed a letter to Health and Human Services Kathleen Sebelius urging the FDA not to approve the drug.

Planned Parenthood, on the other hand, applauded the news and called ella "safe and effective at preventing ovulation and therefore pregnancy."

"Every woman deserves every option available to prevent an unplanned pregnancy, and there are many reasons why a woman may face the risk of unintended pregnancy — from failure or improper use of birth control, to sexual assault," said Cecile Richards, president of Planned Parenthood Federation of America. "The FDA’s approval of this new form of emergency contraception gives women one more option."

In approving Ulipristal, the FDA warned that "it is not intended for routine use as a contraceptive."

The drug ella will only be available by prescription.

The Food and Drug Administration (FDA) on Friday gave its stamp of approval to a controversial pill that prevents pregnancies up to five days after sex.

Available in Europe since May 2009, the so-called ella tablets should be used only as an emergency measure, the FDA said. 

"It is not intended for routine use as a contraceptive," the agency warned.

Plan B, which prevents pregnancies up to three days after sex, has been on the market for more than a decade (and available as an over-the-counter drug since 2006). 

The five-day pill, which has come under fire from anti-abortion activists, will be prescription-only.

A new study funded by the drug industry suggests congressional budget scorekeepers "significantly overstated" the savings from a proposed ban on "reverse payment" patent dispute settlements.

The preliminary economic analysis of the so-called "pay-for-delay" legislation limiting generic drugmakers' ability to accept money to settle patent disputes criticizes the CBO's methodology as well as a previous study by the Federal Trade Commission. In particular, the new study says both the CBO and the FTC were wrong to assume that banning reverse payments would speed up generic entry into the marketplace by 17 months.

"Under many circumstances, reverse payment patent settlements between branded and generic manufacturers can benefit competition and consumers," the study says, "particularly by averting continued litigation that may well delay generic entry substantially." Read more...