2002 was the kind of year that, in hindsight, is difficult to capture in a single theme or symbol — one that defies my usual pithy one-sentence intro remark and leaves me scrambling for cohesion.
Much like the American flags that still hung in windows around the country, the events of 9/11 remained pinned to our minds, adding a backdrop of heaviness to the year. But at the same time, the country was collectively hell-bent on proving its resilience.
It was perhaps a rare moment in history that saw the country united against a common enemy. President George W. Bush had made his now-famed ‘Axis of Evil’ State of the Union Address, outlining plans for combating terrorists and urging a greater focus on security. Later that year, he created the Department of Homeland Security.
In everyday life, the country was fighting to go back to ‘normal.’ The U.S. had been chosen to host the Winter Olympics in Salt Lake City, Utah, and in order to assuage concerns about hosting an international sporting event in the wake of a terror attack, the U.S. government spent more than $225 million on Olympic security. The extensive security measures made the event, at the time, the costliest Olympics in history.
In professional sports, the most celebrated win went to the New England Patriots, after a virtually unknown Tom Brady — just months after his first NFL start — led the team to its first Super Bowl victory. The thrilling win against the highly-favored Rams, which came courtesy of Adam Vinatieri’s last minute 48-yard field goal, resonated with the vibe of the country. People were eager to celebrate the plight of the underdog, admiring a refusal to quit and ability to overcome odds.
In 2002, we were a country in search of heroes and even our movie choices reflected that. Sam Raimi’s first live-action translation of comic book favorite, “Spider-Man,” starring a young Tobey Maguire, brought the story of determination and resilience to the big screen. This brand of heroism rang true with its audience, propelling the movie to box-office blockbuster of the year.
The idea of making a virtually unknown person a star became appealing and millions of people picked up their landlines and called the toll-free number to vote for American Idol’s very first winner, Kelly Clarkson. People who were craving connection could find it through the birth of the modern social media movement. AOL, fresh off a merger with Time Warner (that would soon bring about its demise) still had 26.7 million subscribers dialing up to see if they “got mail” and chatting via Instant Messenger. Friendster was launched in March 2002, successfully translating the real-world ‘friend of a friend’ concept into a digital environment.
The terrorist attacks had ushered in an era of ‘consumer’ patriotism, where corporations realized that Americans were willing to funnel money into the economy as a patriotic act. The post-9/11 economy was set up to encourage buying and this continued into 2002. Car companies had introduced the idea of zero-percent financing, extending interest-free loans for new model cars. Mortgage rates were low and lending standards relaxed, lighting up the housing market. On a smaller scale, consumers were snapping up everything from first generation iPods to Roombas to plasma TVs.
The 2002 pharma world
Medical countermeasures
The combination of 9/11 and the successive anthrax letter attacks had permanently altered the country’s perception of biodefense. This led to a surge in funding allocated to bioterrorism-related pathogens and the development of medical countermeasures.
2002 also marked the start of the first severe acute respiratory syndrome–associated coronavirus (SARS-CoV) outbreak in China. This kicked off a flurry of funding and R&D efforts aimed at producing vaccines and therapeutics against coronaviruses — all of which was promptly abandoned when the immediate threat abated. While fleeting, these 2002 research investments helped create the infrastructure that, come 2020, would prove invaluable.
Regulatory action
Arguably the biggest piece of news to hit the pharma industry in 2002 was the FDA’s revamp of current good manufacturing practices. The last major revision of CGMP regulations had been published back in 1978 and by 2002, new manufacturing technologies had emerged and pharma’s understanding of quality systems had matured — and the FDA was not about to let its guidance stand in the way of industry adoption.
In August of 2002, the agency issued a fresh initiative titled, “Pharmaceutical CGMPs for the 21st Century: A Risk-based Approach.” “We know we can make a good system better,” said then-Deputy FDA Commissioner Lester Crawford in an interview with Pharma Manufacturing.
At the time, the discussion of pharmaceutical CGMPs centered on satisfying compliance standards, and setting a basic threshold for quality management. But the agency purposely left the door open for manufacturers to implement more modern, risk-based approaches, in a form most appropriate for their operations.
“Forward-looking companies, and the FDA, understood the importance of transitioning from routine compliance with CGMP to systems that reflect wider philosophies of continual improvement and quality management,” says Michael Kopcha, director, Office of Pharmaceutical Quality in his commentary inside this issue.
Drug approvals
In 2002, CDER approved a combined total of 23 new molecular entities and new biologics (17 NDAs, 6 BLAs).
Of these approvals, seven had Orphan Drug designation. Keeping the momentum going, the Rare Diseases Act was signed into law in 2002, codifying the National Institute of Health’s Office of Rare Diseases Research and providing for the establishment of the NIH Rare Diseases Clinical Research Network.
Other notable 2002 approvals:
- In February, Idec Pharmaceuticals’ Zevalin, the first conjugated antibody for the treatment of Non-Hodgkin’s lymphoma and the first radioimmunotherapeutic cancer therapy was approved by the FDA.
- In November, Otsuka Pharmaceutical snagged its first approval for future blockbuster, Abilify — the world’s first antipsychotic drug with a dopamine D2 receptor partial agonist mechanism — for the treatment of schizophrenia in adults.
- In December, the future best-selling drug in the world, Humira, won its first FDA approval — for the treatment of rheumatoid arthritis.
U.S. prescription drug sales grew 12% to $192.2 billion in 2002, according to IMS Health. It was the year of the statins: Pfizer’s cholesterol-reducer, Lipitor, was the top-selling drug with $6.1 billion in U.S. sales, followed by Merck & Co.’s competitor product, Zocor, with $4.2 billion in sales.
