Consumer Protection Part 2

FDA's Regulatory Powers

• The FDA operates under three main categories:

  • Surveillance and protection of the public

  • Focuses on both human and veterinary health

Pharmaceutical Industry and Political Influence

• The pharmaceutical industry's economic power translates into significant political influence.

  • Lobbyists often transition between governmental roles and pharmaceutical companies.

  • Substantial contributions to political campaigns enhance industry influence.

Changes in Drug Review Process

• Political pressure has reshaped the drug review process.

  • Designed to ensure drug safety, the process traditionally requires several years.

  • Pharmaceutical companies' objections led to calls for expedited approvals.

  • The 1992 Prescription Drug User Fee Act was a direct result of these pressures.

    • Shortened the FDA's approval timeline.

  • AIDS activists joined forces with pharmaceutical companies to accelerate drug approvals in the 1980s due to urgent health needs.

Impact of Legislative Changes

• 2002 amendments further modified FDA monitoring:

  • Limited monitoring timelines and exempted existing drugs from re-evaluation.

  • Shifted post-approval monitoring responsibility to the pharmaceutical companies.

• Negative outcomes identified:

  • Shortening review time correlated with increased adverse drug reactions:

    • 1% increase in hospitalizations for each month cut from review time.

    • 2% increase in mortality rates due to adverse effects.

Drug Pricing and Accessibility Issues

• Rising drug prices significantly surpass inflation rates.

  • Limited accessibility to essential medications.

• Despite claims of R&D expenses, large marketing and sales budgets exist within the industry.

  • 75% of innovative drugs originate from taxpayer-funded research (e.g., NIH contributions).

• The high cost of drugs escalates healthcare expenses and worsens access to medicines:

  • 58% of Americans rely on prescription medications but face affordability issues.

Opioid Crisis Overview

• The pharmaceutical industry's power exacerbated the opioid crisis.

  • OxyContin was misbranded as suitable for chronic pain despite FDA's limited approval for short-term use.

  • Legal actions resulted in fines without substantive penalties for companies involved.

• Dramatic rise in opioid overdose deaths from 1999 to 2017:

  • Increased five-fold to 218,000 deaths by 2017.

DEA and Industry Interactions

• The industry’s lobbying efforts have weakened the DEA’s regulatory capabilities:

  • Suspensions on suspicious shipments challenged due to political pressure.

  • High-salaried attorneys from the industry obstruct DEA investigations.

• Recent legislative actions (2016) favored the pharmaceutical industry over DEA recommendations:

  • Affected ongoing strategies to regulate painkiller distribution.

  • Congress facilitated these changes with significant campaign contributions.

  • Legislation passed without recorded votes under President Obama, reflecting a lack of transparency.