How Hatch shaped FDA law by finding common ground

A conservative Republican, the late Utah senator worked with liberal Democrats to advance public health

Orrin Hatch, a master at the lost art of legislative compromise, shaped every major piece of FDA legislation for over four decades. His death on April 23 marks the passing of an era in which ideological opponents could be friends and political foes could cooperate to pass laws that made Americans healthier. 

One of the most consequential examples of bipartisan FDA legislation, the law that codified the social contract that underlies the pharmaceutical industry, has come to be known as the Hatch-Waxman Act. It is fitting that Hatch, a teetotaling, anti-abortion conservative who damned much of the Democratic agenda as “socialism” or worse is forever coupled in the legislative firmament with the epitome of a Hollywood liberal, former Rep. Henry Waxman.

Hatch’s collaboration with Waxman wasn’t an aberration. His ability to find common ground and to forge personal relationships with political opponents, most importantly Sen. Ted Kennedy, was key to the enactment of legislation that defines modern drug development.

In addition to the Hatch-Waxman Act, outcomes from the contentious, difficult process of finding overlaps between ideological opponents that Hatch reveled in include the orphan drug, accelerated approval, and breakthrough therapy pathways. He created the legal framework for dietary supplements and played a major role in shaping nutrition labeling. 

That’s just a sampling of his influence on FDA law.

Often, Hatch’s most important accomplishments involved persuading Republicans to support legislation they would likely have instinctually opposed. This was especially true as to public health bills that have produced sweeping benefits, including the Children’s Health Insurance Program (CHIP) that has helped millions of children access healthcare; the Americans with Disabilities Act that has transformed the lives of disabled people in the U.S.; and the reauthorization of the Ryan White CARE Act, a law that provides uninsured people in the U.S. access to AIDS treatments.

Hatch was also key to the enactment of a law that improved procedures for matching organ donors with patients who need transplants. He pushed his colleagues to pass legislation creating a fund for compensating vaccine injury. He then persuaded President Ronald Reagan to sign into law a bill that rescued the U.S. vaccine industry at a time when the threat of ruinous legal judgments was on the verge of making it impossible to develop new vaccines.

The Hatch-Waxman Act

The Hatch-Waxman Act — formally, the Patent Term Restoration Act of 1984 — was a compromise that sought to meet compelling public needs by balancing opposing interests.

The deal was the result of years of public debate, months of intense private negotiations, and a last-minute sprint across the finish line undertaken when a potent opponent had momentarily looked away.

The adventure started in 1980 when Hatch took over the chairmanship of the Senate Labor Committee which had jurisdiction over FDA. Pharmaceutical companies were complaining that by the time they had completed clinical trials of a drug and FDA finished its review, the remaining patent life was often too short to allow for return on development costs.

At the same time, companies that wanted to market generic drugs were stymied by FDA regulations that forced them to recapitulate the clinical trials that had supported approval and then undergo a review process that was as lengthy and uncertain as reviews of new drugs. Very few generics made it to the market, and they weren’t a lot cheaper than the branded products.

These problems were explored in depth in public hearings that dragged on for three years. At the end, Hatch organized confidential negotiations in his office among representatives of branded and generic drug manufacturers.

In his autobiography, Hatch wrote that the negotiations involved a lot of screaming, with each side accusing the other of avarice and bad faith. He defended the decision to negotiate a deal with industry representatives behind closed doors. “One of the realities of Congress is that despite the political benefits of bashing lobbyists, they can be invaluable in their role in providing the technical and practical information necessary to write bills that work,” Hatch said. He added, however, that it is difficult to find lobbyists who “actually understand and can explain the interests they represent.”

At the end of the negotiations, Hatch wrote, some representatives of both branded and generic manufacturers recommended against accepting the deal.

Peter Barton Hutt, a partner at Covington and Burling who represented PhRMA in the discussions, was one of the naysayers.

Hutt told BioCentury that negotiating with Hatch’s counterpart “was one of the most distasteful things I have ever had to do in my life.” In the end, Hutt believed that the deal favored generics companies. “When it was through, I recommended that the industry refuse to go through with what Waxman demanded, but [pharmaceutical companies] felt they had to” go along with it.

Waxman’s refusal to grant more than a five-year period of marketing exclusivity to new drugs led industry to agree to rely on the extension of patent term to compensate for regulatory delays. In Hutt’s view, this was a flawed decision because drug patents weren’t as unassailable as industry believed them to be.

On the other side of the coin, some drug companies have found ways to game the patent system to extend monopolies far beyond the period envisioned by Hatch or Waxman.

The Hatch-Waxman Act unleashed massive quantities of patent litigation, created seemingly endless opportunities for evergreening shenanigans and made it difficult for drug companies to invest in the development of drugs that lack patent protection.

It also has been widely emulated around the world by countries that have embraced the underlying trade-off of a time-limited period of market exclusivity followed by an infinite period of generic competition.

The bill, and the generic drug industry it enabled, almost died in the summer of 1984.

At the end of three years of hearings and months of negotiations in August 1984, Hatch managed to secure time on the Senate calendar for a vote. Given time constraints and impending elections, his only chance to get the bill turned into law was through unanimous consent, a process that can be derailed by a single “no” vote.

Sen. Howard Metzenbaum, an Ohio Democrat, was poised to scuttle the bill when he was called out of the Senate chamber for an urgent discussion with consumer advocate Ralph Nader. Hatch saw his nemesis depart the chamber, cut his speech short, and rushed to submit the bill for unanimous consent.

As the parliamentary gears turned, Hatch watched the doors, knowing that if Metzenbaum caught wind of what was happening, he could register an objection and bury the bill. “Fortunately,” Hatch wrote, “Nader, who rarely does anything with dispatch, took too long. Before he could finish making all his points to Howard, the bill was called up and approved.”

An open mind

Hatch often found ways to work with Democrats on public health and welfare issues not because either side compromised on their principles, but rather by finding small areas of agreement and working to enlarge them. Thus, he helped drive a stake in President Bill Clinton’s attempt to reform the U.S. healthcare system and was among the most adamant opponents of the Affordable Care Act. But he allied with Democrats to get the Children’s Health Insurance Program enacted.

Hatch took firm positions, but he was willing to change them.

His flexibility was key to enactment of legislation that has transformed the lives of millions of people who have rare diseases.

After Waxman had pushed the Orphan Drug Act through the House in 1982, Hatch held it up in the Senate by insisting on stripping provisions rare disease advocates believed were essential. This included providing tax credits for trials of orphan drugs. Hatch’s supporters in the pharmaceutical industry didn’t push back because at the time industry was focused on blockbusters for common diseases and had no interest in developing drugs for rare conditions. They were concerned that FDA might allow orphan drugs to jump the review queue.

Actor Jack Klugman, who had helped push the bill through the House by writing the plight of rare disease patients into the script of a popular television program, created a second show targeted specifically at Hatch. Klugman filmed hundreds of real rare disease patients storming Capitol Hill to protest the intransigence of a fictional senator.

Sen. Hatch got the message, dropped his objection to the tax credits, and took great pride in helping enact the Orphan Drug Act.

Hatch was also a key force behind laws that created the accelerated approval and fast track pathways.

One of his last FDA legislative actions was to successfully insist that the FDA Safety and Innovation Act of 2012 include language creating the breakthrough therapy pathway.

Dietary supplements

While many of his accomplishments made Hatch a hero to public health advocates and he was held in esteem by the pharmaceutical industry as a champion of policies to promote innovation, his actions on behalf of dietary supplement companies dismayed regulators, were opposed by drug companies, and continue to draw criticism from the medical community.

Hatch’s stance on supplements stemmed from distrust of government regulation, belief that U.S. Citizens should be free to decide what products they buy and use, and the political clout of one of the largest industries in Utah.

In contrast to the confidential negotiating sessions that led to enactment of the Hatch-Waxman Act, the senior senator from Utah ran a high-profile campaign for the Dietary Supplement Health and Education Act, encouraging supplement manufacturers and health food stores to mobilize their customers. Millions of pieces of mail poured into congressional offices.

In the end, Hatch wrote in his autobiography that he took advantage of upcoming elections to convince Democrats who opposed the act that “the millions of Americans who supported the legislation were not only writing letters but [were] prepared to vote.”

Viewed from the perspective of drug regulators, the law ties FDA’s hands, preventing the agency from requiring proof of claims made by supplement manufacturers or requiring the kind of premarket data that is standard for medical products. Agency officials are convinced that the law exposes consumers to ineffective and, in some cases, dangerous products.  

The law looks different, however, to executives at food companies. They point out that the law imposes more stringent requirements on supplements than are required for foods.

A vanishing breed

By the last decade of his Senate career, Hatch’s predilection for reaching across the aisle was going out of style. Compromise came to be viewed as capitulation, civility as weakness, and common ground had become a political minefield.

The attacks from Republicans started in the early 1990s. Rivals expressed suspicion at Hatch’s personal friendships with Kennedy and Waxman and questioned his conservative credentials. For example, Hatch, a longtime supporter of gun rights, found himself under intense criticism from Second Amendment advocates because he refused to support legislation guaranteeing worshipers the right to carry concealed weapons in churches, synagogues, mosques and temples.

In 2000, FreedomWorks, a powerful political action committee aligned with the conservative Tea Party movement, funded a “Retire Hatch” campaign and backed a Republican primary challenger.

Hatch prevailed that year and in his next campaign, in part by hitching his wagon to President Donald Trump.

When Hatch stepped away from the Senate in 2019, his friends on the left were gone. Kennedy had died a decade earlier, and Waxman had retired from the House to become a lobbyist. No one on Capitol Hill had Hatch’s deep knowledge of FDA, and there was little enthusiasm for doing the arduous work and taking the political risks required to advance broad, bipartisan legislation.