Medical Devices and Prescription Drug Policy

Significant regulations that impact the health sector should be required to produce an "innovation impact statement," the medical device industry said Monday.

The proposal is among six policy initiatives put forward by the Advanced Medical Technology Association (AdvaMED). They were unveiled during a visit to device maker Stryker's manufacturing facility in Kalamazoo, Mich.  Read more...

Rep. Erik Paulsen (R-Minn.), the co-chairman of the bipartisan House Medical Technology Caucus, told lawmakers on Thursday that he's working on legislation to simplify the approval process for medical devices.

"We're throwing some ideas together right now to help streamline the [Food and Drug Administration]," Paulsen told reporters after testifying at a hearing, "make sure it's a more predictable and transparent process."

Paulsen was testifying at an Oversight and Government Reform Health Care subcommittee hearing regarding the Food and Drug Administration's approval process for medical devices. Critics say Europe approves devices two years faster than the U.S. does, and warn of a pending exodus of cutting-edge medical device companies that currently employ 400,000 workers at 8,000 U.S. firms.

The U.S. medical device sector's supremacy is threatened "not by cheap overseas labor or countries with more competitive tax structures, but by the bureaucracy within our own borders," Paulsen testified. "It's getting harder and harder to bring lifesaving devices to the marketplace in the United States because of a lack of consistency, predictability, and transparency." 

Prescription drugs probably wouldn’t get much cheaper under Democratic proposals to restrict their TV ads and other marketing directly to patients, according to the Congressional Budget Office.

Some Democrats, notably Rep. Rosa DeLauro (D-Conn.) have proposed banning or limiting ads for prescription drugs. They’ve suggested a moratorium could lower drug costs because manufacturers wouldn’t be spending money on TV ads.

But if ads to consumers were restricted, drug makers would simply ramp up their marketing to doctors, CBO said in a report released Thursday. The industry already spends more money selling its products to doctors than it does on consumer advertising.

The medical device industry is pressing Congress to quickly pass the U.S.-Korea Free Trade Agreement.

Korea is one of the largest and fastest-growing markets for medical devices, according to the Advanced Medical Technology Association, or AdvaMed. The group’s president, Steve Ubl, said in testimony to the Senate Finance Committee that the proposed agreement with Korea is the first U.S. trade pact to specifically address his industry.

“Implementation of the FTA would help United States retain and expand jobs in the U.S.,” Ubl said. “Decreasing tariff and non-tariff barriers will obviously lead to more sales of U.S. medical technology products in Korea. Implementation of the FTA would therefore benefit not just the medical technology sector, but also would create positive collateral benefits to the U.S. economy as a whole.”

According to his testimony, the U.S. exported about $875 million in medical devices to Korea last year and the market there is expected to grow by 10 to 15 percent.

Senate Finance Chairman Max Baucus (D-Mont.) and Sen. Chuck Grassley (R-Iowa) are urging the Food and Drug Administration to increase transparency in its citizen petition process in the wake of alleged abuses by the drugmaker Sanofi.

The process allows individuals and health experts to raise concerns about the safety of medicines regulated by the FDA. But a new congressional investigation alleges that Sanofi paid more than $5 million to two medical groups and a researcher who unsuccessfully used the process to try to delay or prevent approval of generic versions of the blockbuster blood-clot treatment Lovenox.

"Generic drugs help keep health care costs down and we absolutely cannot let powerful drug companies keep those life-saving drugs out of reach," Baucus said in a statement. "This report uncovers evidence that paying off doctors to lobby the FDA against generics was a drug company strategy — and that's wholly unacceptable. The FDA needs to work closely with doctors, so we must ensure that doctors' sole motivation is the well-being of their patients."

Sen. Jerry Moran (R-Kan.) will lead a caucus for pharmacists as they push for bills to expand access to community pharmacies.

The National Community Pharmacists Association hasn't historically been represented by a Senate caucus, but Moran — a former leader of the House pharmacy caucus — agreed to take up the charge, NCPA officials said Tuesday.

Community pharmacists are gathered in Washington this week for a policy conference and to lobby members of Congress for bills they say would lower healthcare spending.

John Coster, NCPA's senior vice president of government affairs, said the group will press for a bill that would exempt community pharmacists from competitive bidding for diabetes supplies.

Other long-standing pharmacy priorities include a crackdown on the companies that administer health plans' drug benefits. Reps. Cathy McMorris Rodgers (R-Wash.) and Anthony Weiner (D-N.Y.) introduced a bill Tuesday to bring more transparency to those companies, which pharmacies say drive up the cost of prescription drugs.

Two-thirds of small medical device makers are turning to Europe first to get approval for their products, researchers at Northwestern University write in a new report.

The report comes as the Food and Drug Administration (FDA) is revamping its approval process for low-risk products amid complaints that the process is too slow and unpredictable. Consumer advocates, meanwhile, say dangerous devices are still slipping though the cracks.

According to the new survey, only 8 percent of survey respondents said the FDA's 510(k) approval process is the most predictable. Meanwhile, fully 98 percent said the predictability of the regulatory process is a "crucial factor" in their decision to invest in developing a new product.

"As FDA considers regulatory revisions," lead researcher John Linehan said in a statement, "what's at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace."

The chairman of the Senate's antitrust panel on Thursday urged the Federal Trade Commission to pay special attention to prescription drug shortages when weighing whether to approve pharmaceutical industry mergers.

"Maintaining a competitive pharmaceutical market is the highest priority, and these reports of drug shortages are very troubling to me," Sen. Herb Kohl (D-Wis.) wrote to FTC Chairman Jonathan Leibowitz. "While I recognize that often shortages are likely to have causes not related to these competition issues, antitrust enforcers — particularly when reviewing drug company mergers — must be cognizant of these shortages when applying antitrust law to the drug industry."

The pharmaceutical industry has seen at least nine megamergers during the past decade, Kohl wrote, and a record 211 medications suffered shortages in 2010. Kohl also points to a 2009 government report that found that "[f]ewer drug companies competing in a therapeutic class may lead to fewer prescription drugs being developed and sold within that class."

Kohl is chairman of the Senate Judiciary Committee's antitrust panel, which has oversight over the FTC.

The Food and Drug Administration wants some drugmakers to pay a fee for meetings early in the process of developing a new product.

The FDA already collects user fees to cover the cost of reviewing brand-name prescription drugs. The agency said it wants to begin collecting that money earlier for a new class of drugs created by the healthcare reform law.

The law gave the FDA the power to approve drugs known as biosimilars — in essence, generic versions of biological drugs, which are more complex than traditional pharmaceuticals.

The number of so-called "pay for delay" settlements in patent disputes over prescription drugs increased by 60 percent in 2010, the Federal Trade Commission said in a report Tuesday.

The FTC has pressed Congress to outlaw the settlements, which it believes are anticompetitive. A ban was proposed during the healthcare reform debate but didn't make it into the final bill.

The FTC says "pay-for-delay" settlements cost consumers and the government more than $3 billion per year in higher drug costs. The term refers to cases in which a brand-name drug maker sues a would-be generic competitor for patent infringement, then the parties reach a settlement in which the brand pays the generic and the generic agrees to stay off the market for a certain period of time.

“The FTC is continuing to perpetuate the myth that pro-competitive, pro-consumer patent settlements are harmful to consumers — an unsubstantiated position that has repeatedly failed to receive support in both Congress and the Courts," the Generic Pharmaceutical Association said in a statement.

Both brand-name and generic manufacturers oppose new limits on their patent settlements.