FDA Archives - Shopfloor

Keep Innovation Alive and Safe

By | Shopfloor Policy | No Comments

Today, the Senate HELP Committee marks up S. 934, Food and Drug Administration Reauthorization Act. In a March letter to the Committee leaders, the NAM expressed its strong support for a swift and timely reauthorization of the Food and Drug Administration user fee agreements covering prescription drugs, medical devices, biosimilars and generic drugs. Manufacturers urge the Committee to maintain its momentum so that S. 934 can stay on schedule, ahead of a September 30 deadline. Any delay of the FDA Reauthorization Act risks future gains in medical discovery and harm to our global standing. Read More

New Added Sugars Label Rule Risks Manufacturers’ Trade Secrets

By | Regulations, Shopfloor Policy | No Comments

On Friday, the Food and Drug Administration (FDA) released a 1,000-page rule creating new requirements for nutrition labels. Manufacturers have serious concerns about the FDA’s new mandate to place “added sugars” on the list of nutrients declared on the facts panel.

Despite the FDA’s own admission that there is no nutritional difference between added sugars and naturally occurring sugars, the agency has issued a misguided mandate that is immensely burdensome for manufacturers. Consumers already have nutritional information about sugars. The addition of added sugars on the facts panel implies that a nutritional difference exists. This can actually misinform the public.

Manufacturers are also concerned about the burdensome recordkeeping and reporting requirements that would require the disclosure of protected and confidential information. The FDA’s demand that a manufacturer be forced to hand over proprietary information upon request to an inspector creates a dangerous precedent.

President Obama’s Executive Order 13563 reaffirms the principles for sound rulemaking, stating that our regulatory system “must be based on the best available science.” The FDA clearly has not developed this costly and unnecessarily burdensome regulation in accordance with this principle.

Texas Gov. Perry: ‘I Don’t Want National Tort Reform’

By | Briefly Legal, General, Health Care | One Comment

During his briefing with bloggers today, Gov. Rick Perry of Texas repeatedly turned to the federalism and the 10th Amendment of the Constitution as core principles informing his approach toward domestic policy issues. Let states like Maryland or California experiment with high taxes or more regulations while Texas does the opposite, he argued. The American people can choose where they prefer to live.

We noted that several conservative Republicans on the U.S. House Judiciary Committee had expressed opposition to H.R. 5, the medical liability reform bill, on just those grounds.

“I don’t want national tort reform,” Perry said forcefully.

Let me tell you why. We have medical tort reform in the state of Texas. It works. We are a haven.  Twenty-six thousand doctors have applied to practice medicine in Texas since 2003 when our tort reform became the law in Texas. Here’s what disturbs me: If they pass a national bill, I would bet you dollars to donuts, it is weaker than what we’ve got in Texas. So our physicians would be in a less favorable position from the standpoint of protection from frivolous lawsuits. …

I don’t ever get confused that this issue’s about doctors. It’s about access to care, because what we’ve seen in Texas – and I don’t want to spend too much time on this — but what we’ve seen in Texas was that because of the proliferation of frivolous lawsuits that occurred in Texas in the ‘90s and the early part of the 2000s, you had particularly high risk for specialties like OBY-Gen, orthopedic surgeons.


In the grand and global sense, anything in the constitution about tort reform? Leave that to the states. Come down and actually put the people on the border. Put the aviation assets in the air so we can have the protection for our citizens, and frankly, the Mexican citizens as well, and stop these drug cartels. That IS a federal responsibility that they are abject failures at, at present.

The first quotes are here as an .mp3 file, and the second cut is here.

The governor’s position, most directly applicable to caps on punitive damages, is not a popular one with House Republicans who view medical liability reform as an important element of their drive to control health care costs.

There are provisions H.R. 5 that clearly involve interstate commerce and are thus appropriate for federal legislation, specifically the treatment of drugs and medical devices that are approved by the Food and Drug Administration. See our post, “Why Medical Liability Reform Matters to Manufacturers.”

Circumnetting Today’s Washington Post

By | Culture and Entertainment, Infrastructure, Innovation, Regulations | No Comments

Many items of interest and irritation in today’s Washington Post relating to the economy and manufacturing.

Why overregulate leading U.S. innovators?FDA approval process faulted at hearings on medical devices,” covering last week’s hearing on medical device regulation in the House Energy and Commerce Subcommittee on Health:

FDA leadership is in the process of overhauling the 35-year-old system used to clear most devices, triggering a slew of reports and analyses aimed at influencing the agency’s plans.

On the one side are device manufacturers, who say that FDA reviews have gotten longer and less predictable, forcing some companies to launch their devices overseas to stay in business. They say American patients no longer have access to the latest medical treatments, forcing some to fly to Europe for surgery.

Infrastructure took only 40 years?Md.’s Intercounty Connector gets ribbon-cutting as opening is delayed for snow”:

Given that officials once thought the Intercounty Connector would open by 1970, the fact that they finally cut the ribbon on Monday and then postponed the opening until Wednesday seemed very much in keeping with the story line. Read More

Why Medical Liability Reform Matters to Manufacturers

By | Briefly Legal, Health Care | 2 Comments

The House Judiciary Committee continues to work on H.R. 5, the medical liability reform package, today in an afternoon mark-up session. We wish them well on the effort. Liability reform will help control the rising costs of health care, and this specific piece of legislation — called the HEALTH Act — contains important protections for drugmakers and medical device manufacturers. The language reflects the understanding that drugs and devices are sold into interstate commerce, approved and regulated by the federal Food and Drug Administration, and once demonstrated as safe should not be subject to trial lawyers’ efforts to use state courts to play litigation lottery.

Section 7 of the legislation, Punitive Damages, sets guidelines on punitive damage awards in health care lawsuits, including limits so punitive damages awards do not exceed the greater of $250,000 or twice economic damages.

Manufacturers of drugs and medical devices are most interested in paragraph (c), “No Punitive Damages for Products That Comply With FDA Standards.


(A) No punitive damages may be awarded against the manufacturer or distributor of a medical product, or a supplier of any component or raw material of such medical product, based on a claim that such product caused the claimant’s harm where–

(i)(I) such medical product was subject to premarket approval, clearance, or licensure by the Food and Drug Administration with respect to the safety of the formulation or performance of the aspect of such medical product which caused the claimant’s harm or the adequacy of the packaging or labeling of such medical product; and

(II) such medical product was so approved, cleared, or licensed; or

(ii) such medical product is generally recognized among qualified experts as safe and effective pursuant to conditions established by the Food and Drug Administration and applicable Food and Drug Administration regulations, including without limitation those related to packaging and labeling, unless the Food and Drug Administration has determined that such medical product was not manufactured or distributed in substantial compliance with applicable Food and Drug Administration statutes and regulations.

Trial lawyers have long sought to bring suits against drug and device makers into state courts, seeking venues and judges that favor the plaintiffs and huge damage awards. In the 2008 decision in Riegel v. Medtronic, the U.S. Supreme Court limited such state suits against manufacturers of medical devices that had received pre-market approval from the FDA. The court ruled that Congress had specifically preempted the devices from state regulation under § 360k(a) of the Medical Device Amendments to the Food, Drug and Cosmetic Act.

This decision was critical in affirming the principle of federal preemption, which provides effective protections for public health and safety. Congress has determined that the FDA is the proper authority with the available resources to regulate drugs and devices in interstate commerce.  Lawsuits in state courts in effect create a 50-state system of regulation for these devices and drugs, full of inconsistencies, capricious enforcement and unjustified damage awards. (No wonder the American Association for Justice and other trial lawyer lobbyists sought to reverse the Riegel decision last Congress with the so-called Medical Device Safety Act. Thankfully, they failed.)

The language in H.R. 5, Section 7, paragraph(c) draws on that general principle of preemption for its “safe harbor” language. It holds that companies that manufacture drugs and devices recognized as safe by the FDA have by definition gone through the careful development, testing and approval — the due diligence — that demonstrate the companies did not behave in a way to justify punitive damages. The legislation provides a measure of protection for companies so they can manufacture effective drugs and devices. It’s exactly the kind of medical liability reform that will reduce costs while ensuring a dynamic market that innovates and creates live-saving products.

UPDATE (4:50 p.m.): The House Judiciary Committee just voted 16-20 to defeat an amendment offered by Reps. Mike Quigley (D-IL) and Sheila Jackson-Lee (D-TX) to strike  Section 7. Rep. Franks (R-AZ) successfully opposed against the amendment, making a similar case as argued above.

Food Safety Modernization Act Passes Senate, Back to House

By | Energy, Regulations | One Comment

The Senate revived the Food Safety Modernization Act on Sunday, correcting its error to obey the U.S. Constitution’s requirement that revenue measures — in this case, a fee on companies involved in food recalls — originate in the House of Representatives.

The new language comes in a form of the amendment, SA 4890 (printed in The Congressional Record here), to H.R. 2751, Consumer Assistance to Recycle and Save Act, aka the “Cash for Clunkers” program. Don’t imagine we’ll see anything involving free money for old cars in the 112th Congress.

A dozen major trade associations representing food and beverage manufacturing, including the National Association of Manufacturers, on Nov. 30 sent a letter  urging the House of Representatives to approve the previous version of the bill, S. 510.

Coverage of Senate action:

For Food Safety and Regulatory Certainty, House Should Pass S. 510

By | General, Regulations | 8 Comments

The Senate this week provided a strong and bipartisan 73-25 vote to pass S. 510, the Food Safety Modernization Act, and the House is up next to consider the bill. This is important legislation that can and should be enacted into law during the current lame-duck session of Congress.

The National Association of Manufacturers and other trade associations sent a letter to House leadership on Tuesday urging quick passage. Excerpt:

Strong food-safety legislation will reduce the risk of contamination and provide FDA with the resources and authorities the agency needs to help make prevention the focus of our food safety strategies. Among other things, S. 510 requires food companies to develop a food safety plan, improves the safety of imported food and food ingredients, and adopts a risk-based approach to inspection.

Manufacturers believe that the legislation strikes the right balance of additional authorities and resources for the Food and Drug Administration. Consumers should have confidence in our food safety and surveillance system and this legislation will further improve it.

Swift passage is also crucial to give companies clarity about the regulatory environment they will be facing in food manufacturing and processing, so that investments can be made in new technology and facilities. Without passage of this law, the industry will face continuing uncertainty which creates havoc for business planning and investment. One of the many elements necessary for economic recovery is regulatory certainty. Congress has the ability to provide a measure of that before it adjourns.

Rosario Palmieri is the National Association of Manufacturers’ vice president for infrastructure, legal and regulatory policy.

The Anti-Speech, Anti-Business Implications of Graphic Tobacco Labels

By | First Amendment and Lobbying, General, Global Warming, Media Relations, Regulations | No Comments

USA Today on Friday editorialized in support of warning labels on cigarette packs meant to repulse would-be smokers by showing them images of disease, death and doom. As the headline suggests, “Graphic warnings turn tables on cigarette marketers,” the core argument is that after all the advertising those lousy tobacco companies have done, why, they deserve it.

It’s always troubling to see newspaper opinion pages argue against First Amendment rights. Thankfully, as is its practice, the paper printed a rebuttal directly below its editorial, a piece by Dan Jaffe, executive vice president of government relations for the Association of National Advertisers. From “A massive censorship scheme“:

Unlike all other governmentally mandated ad disclosures, this is not simply a requirement to provide truthful, neutral information to the public. Rather, it is a transparent effort to utilize the cigarette pack and ads to stigmatize the product and as a medium for the government’s anti-tobacco messages.

The Supreme Court has made clear, however, that private companies cannot be coerced to spend or utilize their own money or property to become the government’s ventriloquist dummies, billboards or megaphones.

Despite claims to the contrary, these proposals would create broad precedents for the advertising community. The Supreme Court forcefully holds that all product categories, however controversial, have equal protection under the First Amendment.

Nor is it plausible that these proposals, justified on the powerful convincing impact of visual imagery, will be applied only in the “unique” case of tobacco.

We’re reminded of EPA’s recent labeling scheme, sticking letter grades on vehicles according to their fuel-efficiency. What happens when the public insists on continuing to buy cars that get a B-minus grade or below? Instead of an educational label, which is what the original cigarette labels were, we can imagine exhortations — “You can help save the environment by buying vehicles with higher grades than C” — and then demonizations: “If you buy this car, you are helping to cause rising ocean levels that will drown the people of Nauru and Bangladesh, especially all the children who can’t swim.” And then, the graphic photos.

Reduction ad absurdum and slippery slope arguments, we know. But it’s also history.

FDA Medical Device Proposal: Undercutting U.S. Success Story

By | Health Care, Regulations | No Comments

The medical device industry is a textbook story of manufacturing success in the United States. This industry, comprising manufacturers of devices and diagnostics, is a sector of the manufacturing where the U.S. leads the world. Medical technology represents the 11th largest manufacturing sector in terms of exports and has consistently maintained a favorable balance of trade. Yet, actions being considered by the Food and Drug Administration with respect to the approval of devices threaten to stifle innovation and cost Americans jobs.

The FDA is considering making changes to the 510(k) approval process, which in its current form, demonstrates an exemplary record of safety and effectiveness. (Federal Register notice.) However, despite significant increases in resources made available to the FDA through user fees and appropriations enacted as part of the Medical Device User Fee Act in 2002 and reauthorized in 2007, performance at the agency has markedly declined since 2003. For example, total review times, number of review cycles, amount of time manufacturers spend answering FDA questions after products are submitted for review or the withdrawal of applications before a final decision have gone up – even with the additional resources afforded the FDA. So what’s the answer from the agency? Notwithstanding an outstanding safety record, they want to make it more difficult and time consuming to get new products to patients.

The proposal under review at the FDA would do the following:

  • Impose arbitrary limits on acceptable predicate devices
  • Redefine the term “substantial equivalence”
  • Eliminate separate classification of intended use and indications for use

As the National Association of Manufacturers argues in a joint comment letter with the U.S. Chamber of Commerce, making these changes will increase approval time and costs with no appreciable benefit to consumer safety or device effectiveness. Indeed, such changes could negatively affect public health by curtailing the availability of needed treatments and cures. The FDA should carefully reconsider these proposals and err on the side of doing no harm to a process and an industry to which many Americans owe their lives and livelihood.

Joe Trauger is vice president of human resources policy at the National Association of Manufacturers (NAM).

Reasonable Regulations, Resources for Food Safety

By | Regulations | 2 Comments

The Des Moines Register reports on a news conference Monday that included representatives from business associations and “consumer activists,” both supporting a new food safety bill that might be considered soon in the U.S. Senate. From “Big biz, consumers ally on food safety“:

Consumer advocates and big business are at odds more often than not but they’re getting together this week to call on senators to pass a food-safety bill before they Washington to campaign. Officials with the Grocery Manufacturers Association and the National Association of Manufacturers appeared at a news conference today with representatives of several major consumer groups, including the Consumer Federation of America and the Center for Science in the Public Interest.

The bill would increase food inspections, require food makers to have plans for preventing contamination, authorize growing standards for fruit and vegetable growers, and provide the Food and Drug Administration with new authority to oversee farms and processors.

Rosario Palmieri, a vice president of the National Association of Manufacturers, said the legislation would “bring certainty to food and beverage manufacturers as well as the supply base that supports them.”

The bill is S. 510, the FDA Food Safety Modernization Act. Its progress has been slowed if not stalled in the Senate because of a variety of objections. (See news coverage below).

The news release from the Grocery Manufacturers Association makes the case for the bill. From “Food and Beverage Industry, Consumer Groups and Non-Governmental Organizations Call on Senate to Pass Bi-Partisan Food Safety Bill“: Read More