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Newly appointed FDA Chief Counsel Rebecca “Becky” K. Wood just started the best and most challenging job an attorney in the food and drug law field could have, according to four who’ve had the job.
“One of the things that makes it a great job is there are great legal issues that literally come up every day,” Ralph Tyler, chief counsel from 2010 to 2011, said in a recent interview. “There are major interesting challenges and novel legal and programmatic questions.” Tyler is now at Venable LP in Baltimore.
Wood, who started in July 10 at the agency, wasn’t available for an interview, but Bloomberg BNA talked to four people who held the top attorney job about the challenges and rewards of the FDA position. The new top FDA lawyer is starting at a time when the agency is facing legal pushback on its restrictions on what companies can say about their products. The agency is trying to keep up with safety concerns stemming from a global supply chain for drugs, devices, and other regulated products.
The chief counsel helps the Food and Drug Administration’s commissioner meet the agency’s public health goals and guides the agency’s enforcement agenda against regulated companies including medical device and drug manufacturers.
“It was one of the very best jobs I ever had,” Gerald Masoudi, agency chief counsel from 2007 to 2009, and now at Celgene Corp., said in an Aug. 7 interview. “Every day, an interesting new legal issue would come up.”
FDA Commissioner Scott Gottlieb chose Wood, formerly with the law firm Sidley Austin, to be the agency’s top lawyer. Wood replaces long-time chief counsel Elizabeth H. Dickinson, who served in the position from 2011 to July 2017. Dickinson is staying at the agency in another position in the counsel’s office.
The FDA’s Office of the Chief Counsel (OCC) is the Food and Drug Division of the HHS’s Office of the General Counsel, and the office employs litigators who handle cases involving FDA-related matters and counselors who advise FDA and HHS officials on matters involving FDA-regulated products, including drugs, biologics, medical devices, radiation-emitting products, veterinary products, food, cosmetics, and tobacco products.
Litigators in the OCC handle both civil and criminal enforcement cases and defend challenges to provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), its implementing regulations, and FDA policies, initiatives, and decisions. Although the Justice Department attorneys generally are responsible for representing the FDA in court, OCC litigators work closely with the DOJ and play an active role in all of the FDA’s cases.
The FDA lawyers review and revise draft and final regulations, draft and final guidance documents, respond to citizen petitions asking the agency for action, and draft legislation. They also review agency officials’ congressional testimony and help the FDA respond to congressional and Freedom of Information Act requests.
Over time, the number of lawyers in the OCC has grown exponentially and that growth has affected the nature of the chief counsel job, Richard Cooper, now of counsel at Williams & Connolly LLP, in Washington said. Cooper was chief counsel from 1977 to 1979. “The office is twice the size of when I left,” Cooper told Bloomberg BNA Aug. 1. “That’s obviously means much more managerial responsibility and more of a challenge to have face-to-face relationships.”
“It’s a wonderful group of very smart lawyers,” Masoudi said. “Building relationships with them is one of the most important parts of the job.”
It’s also important for the chief counsel to be decisive in the face of uncertainty, Masoudi said.
“You need essentially an inside and an outside chief counsel,” Peter Barton Hutt told Bloomberg BNA. Hutt, chief counsel from 1971 to 1975, is now of counsel at Covington and Burling LLP in Washington. “Figure out your own agenda and proceed to implement it,” he said in a July 31 telephone interview.
The OCC’s heavy workload means there is a need to set priorities, Tyler said in late July. “Otherwise, you’ll just be responding to things.”
Under long-standing policy at the FDA, companies can be subject to criminal prosecution and civil liability if they promote products for off-label uses the FDA hasn’t specifically approved. But industry has criticized the policy as unduly restrictive and claim it infringes manufacturers’ free speech rights.
The biggest issue facing the OCC is the application of the First Amendment to everything the FDA does, the lawyers said.
The FDA needs to start taking the First Amendment seriously, he said, and respect the limits it puts on the agency’s regulatory authority, Tyler said.
“FDA does two things: it regulates substances and it regulates words—what people say about those substances,” Hutt said. Fifty percent of what the FDA does is governed by the First Amendment, he said.
Meanwhile, “the FDA’s track record in court is nothing sort of disastrous,” he said. “They have totally lost credibility in courts on the First Amendment and that’s not a good place to be in.”
The drug and device industries have been pushing the FDA to clarify its policy on medical product communications for several decades. Court cases challenging the constitutionality of the agency’s off-label promotion regulations have raised doubts about whether the federal government can continue to restrict manufacturers from sharing truthful information about the off-label uses of drugs and medical devices.
“My advice is for the FDA to create meaningful ways for manufacturers to communicate scientifically valid information about their products,” Masoudi said. “It’s good for the agency because it won’t have a court telling it what to do.”
“If there are not meaningful avenues for off-label communication, the agency may be forced [by the courts] to take a position that may be worse,” he said.
Although a lot of the litigation the FDA is engaged in is reactive, such as responding to cases in which it has been sued, the agency also pursues its own enforcement priorities, and it has been criticized for both underenforcing and overenforcing the law.
“The pendulum seems to swing between heavier enforcement and lighter enforcement and between safety concerns and approval concerns,” Masoudi said.
In some cases, enforcement can lead to unforeseen consequences, he said, including drug shortages stemming from a facility shut down for manufacturing violations.
To make sure enforcement agenda is carried out in the best interest of the public, Masoudi said the chief counsel should closely coordinate with the U.S. Attorneys offices within DOJ.
In some cases, Masoudi said, the FDA may have a different view from the DOJ on certain matters, especially in the promotion and labeling area. “I think they [the DOJ] may not fully understand the consequences of pursuing certain actions and investigations. When it’s gone pretty far down the road, even an investigation can put a strain on a company or individual,” he said.
Another challenge facing the agency is the increasing globalization of the products it regulates, with more and more of those products or product ingredients manufactured abroad. The growth in overseas production is attributable in part to cheaper foreign production costs and often less regulatory scrutiny of foreign suppliers.
“Globalization is the biggest institutional change facing the FDA; the FDA was an agency established to regulate products grown or manufactured in the U.S.,” Tyler said.
Globalization is a logistical challenge for the FDA,” Masoudi said. “The increase in globalization logistically makes it much more difficult for FDA to stay on top of things with the free flow of goods.”
It’s an impossible burden on FDA, Hutt said. “How do you inspect the 80 percent of active ingredients that are manufactured abroad? Without higher appropriations, you’re not going to have an adequate inspection system.”
A December 2016 General Accountability Office report concluded globalization has complicated FDA’s oversight of drugs marketed in the United States, with more than 40 percent of finished drugs and 80 percent of active pharmaceutical ingredients produced overseas in more than 150 different countries. In addition, the report found vacancies were “persistently high” in the FDA foreign offices monitoring the manufacturing of drugs overseas.
Resources are a perennial issue for the agency, too, the lawyers said.
Industry now pays user fees to help fund FDA operations, along with congressional appropriations. In return for the fees, the agency commits to meet certain performance goals. The FDA has separate user fee programs for prescription drugs, generic drugs, biosimilars, and medical devices. On Aug. 18, President Donald Trump signed the latest round of user fees, which will provide funding for five years starting in fiscal 2018.
There has been criticism that the user fees funding have caused the FDA to be captured by industry, but the ex-chief counsels dismissed that criticism entirely.
“It’s not as if PDUFA [the Presciption Drug User Fee Act] has been a payment made in exchange for some particular action on a particular product. They’re general guidelines that are across the board goals,” Masoudi said.
“There certainly is a very important question about the wisdom of funding government through user fees,” Tyler said. “But the funding has nothing at all to do with how FDA does its job,” Tyler said. “People don’t sit around and act one way or another. User fees have been a default given the increase in the agency’s responsibilities.”
“The career people at FDA genuinely seek to serve the public, not the industry,” Cooper said.
The lawyers differed on whether federal food and drug law has kept pace with new and emerging technologies.
Hutt and Cooper told Bloomberg BNA the FDA’s statutory tools were written broadly enough to encompass new technologies.
“The question in my mind is always, ‘Have these [technological] changes revealed weaknesses in the law or concepts that would have led to a different result?’” Hutt said. “The [food and drug law] was a statute written in broad sweeping terms. It laid down general principles, not operational rules.”
“It was broad enough and easily interpreted to encompass anything I encountered and could foresee,” Hutt said.
Cooper agreed. “In general, FDA has the statutory tools it needs. Those tools can be modified and added to,” he said.
“The specific issues have changed, but the basic concept is no different. The question is how should you as an agency deal with these issues?” Hutt said.
But Masoudi and Tyler were more doubtful whether the statute and regulations could keep pace.
“In my view, technologies are changing faster than FDA has kept up,” Masoudi said. “Medical technology is moving very quickly, and the statutory tools don’t always necessarily fit,” he said.
Masoudi gave the example of the agency’s development of guidance on transgenic animals, organisms whose genomes have been altered by transferring genes from another species or breed of animal.
“We had to decide whether the genetic material would be regulated or would the animal that resulted be regulated? We decided to use the drug authority, not the food authority, but the choice wasn’t clear-cut.”
“Technology moves faster than regulation,” Tyler said. “If you approached every statutory question from the perspective of what was the outcome intended here, you’d never come up with an answer because Congress never contemplated them or maybe the issue never existed.”
To contact the reporter on this story: Dana A. Elfin in Washington at firstname.lastname@example.org
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