The FDA, Again?!?

You know, it seems just yesterday I was bagging on the FDA.  

In today's blog post, I'm complaining about drugs and why is it the FDA isn't doing a better job of regulating Big Pharma.

In fact, and did you know, that there are ONLY TWO countries that allow pharmaceutical companies to advertise to the public?  The United States and New Zealand.

That's it.

Did you also know that under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA regulates prescription drug ads. 

That's right.  Pursuant to FDA rules, companies must:

• Present a “fair balance” of risks and benefits.

• Not omit important safety information.

• Ensure claims are truthful and not misleading.

Soooooo, what happens when a pharmaceutical company doesn't present a fair balance of risks and benefit OR omits important safety information OR ensures claims are truthful and not misleading?

Well, they get fined or get sent a really nasty letter.

A letter?  You're kidding right?!

Actually, no.  

Officially, if a company misleads the public (e.g., downplays side effects), the FDA can issue:

• A scary warning letter or Untitled Letters (formal notices to stop certain ads).

• Seizure or injunctions (rare).

• Referral to the Department of Justice (DOJ) for civil or criminal prosecution.

But, you say, the FDA doesn't really send out letters when there is a clear violation by a BILLIONS in profit each year MULTINATIONAL corporation?

Say it isn't so, Joe!

1. Celgene – Revlimid (2015, Untitled Letter)

• Issue: Promotional materials overstated effectiveness in treating multiple myeloma and downplayed risks.

• FDA Action: Issued an untitled letter directing Celgene to correct the materials.

• Criticism: No fine or sanction, even though Revlimid was a multi-billion-dollar drug.

2. Amgen – Neulasta (2010, Warning Letter)

• Issue: TV ad minimized serious risks (e.g., spleen rupture, acute respiratory distress) and overstated benefits for chemotherapy patients.

• FDA Action: Sent a warning letter. The ad was pulled, but no financial penalties were imposed.

3. Novartis – Tasigna (2013, Untitled Letter)

• Issue: Website and YouTube videos exaggerated the cancer drug’s effectiveness while minimizing life-threatening side effects.

• FDA Action: Issued an untitled letter requiring corrections, but no fines.

4. Otsuka – Rexulti (2016, Warning Letter)

• Issue: Sales reps made false claims to physicians, suggesting Rexulti was safer and more effective than proven.

• FDA Action: Sent a warning letter. Again, no penalties beyond compliance.

5. AstraZeneca – Seroquel XR (2009, Warning Letter)

• Issue: Print ad overstated effectiveness for generalized anxiety disorder and omitted major safety warnings (including metabolic risks).

• FDA Action: Warning letter only — no fines.

OK, OK, so they send out letters.  But no fines/money?  There's gotta be instances where companies who violate the law get fined, right?!? 

Well, yes - fines are levied.  The problem is when the company makes BILLIONS in profit each year, any fine is basically a tickle.  For example:

1. GlaxoSmithKline (GSK) – Fined $3 billion (2012)
• Drugs: Paxil, Wellbutrin, Avandia
• Violation: Misbranding, illegal promotion, and failure to report Avandia’s cardiovascular risks.
• Profit in 2012: $7.1–7.5 billion USD  
2. Pfizer – Fined $2.3 billion (2009)
• Drug: Bextra (and others)
• Violation: Off-label promotion, false marketing, and kickbacks.
• Profit in 2009: About $8.6 billion USD
3. Johnson & Johnson – $2.2 billion (2013)
• Drug: Risperdal (antipsychotic)
• Violation: Misbranding and hiding risks, especially promotion to elderly patients despite stroke risk.
• Profit in 2013: $13.8 billion USD
4. Abbott Laboratories – $1.5 billion (2012)
• Drug: Depakote
• Violation: Promoting for unapproved uses (e.g., dementia, schizophrenia).
• Profit in 2012: $6.0 billion USD
5. Eli Lilly – $1.4 billion (2009)
• Drug: Zyprexa (antipsychotic)
• Violation: Off-label promotion (especially to children and elderly) while downplaying diabetes risks.
• Profit in 2009:  $4.33 billion USD
6. Merck – $950 million (2011)
• Drug: Vioxx (painkiller)
• Violation: Misbranding and failing to disclose cardiovascular risks.
• Profit in 2011: $6.27 billion USD
7. Amgen – $762 million (2012)
• Drug: Aranesp (anemia drug)
• Violation: Misbranding, off-label promotion, false claims to Medicare.
• Profit in 2012: $4.3 billion USD
8. Allergan – $600 million (2010)
• Drug: Botox
• Violation: Promoting for unapproved uses (headaches, juvenile cerebral palsy, pain).
• Profit in 2010: $0.28 billion on revenue of $4.8 billion USD
9. Schering-Plough/Merck – $435 million (2006)
• Drug: Temodar, Intron A, others
• Violation: Off-label promotion, false claims.
• Profit in 2006: $1.6 billion USD
10. Purdue Pharma – $634.5 million (2007)
• Drug: OxyContin
• Violation: Misbranding, falsely claiming OxyContin was less addictive and safer than other opioids.
• Total Revenue in 2007: $2.8 billion USD

What does all this indicate?  Simply, that money is no option for some companies.  Even though Purdue Pharma got hit with a $634.5 million fine, it was still not enough to sink the company because there is so much money in drugs.

So, why doesn't the FDA hit Pharma companies harder? Well, up to now, the Feds were in bed with Big Pharma.

The most direct evidence of bribery occurred in the late 1980s, where an industry whistleblower uncovered a major scandal involving FDA officials.

• What happened: Several FDA employees in the generic drugs division were found to have accepted bribes and illegal gratuities from generic drug companies. In exchange, officials sped up drug approvals or provided inside information.
• The outcome: The scandal led to criminal convictions and prompted the FDA to implement new policies to detect fraudulent data submissions and address bribery

Outside of direct bribery, critics point to other structural issues that can create a "cozy relationship" between the FDA and the pharmaceutical industry. 

• User fees: Since 1992, the FDA's drug division has been partially funded by "user fees" collected from pharmaceutical companies. This system raises concerns about a potential conflict of interest, as the FDA becomes dependent on the industry it regulates.
• The "revolving door": It is a common practice for senior FDA officials and drug reviewers to leave the agency and take high-paying jobs at the pharmaceutical companies they once regulated.
  • Potential concerns: This practice raises concerns that former officials could use their inside knowledge and relationships to benefit their new employers.
  • Arguments for the practice: Supporters argue that the deep knowledge of former FDA employees can help companies navigate the complex approval process more efficiently. 

The pharmaceutical industry also has a documented history of paying illegal kickbacks and bribes to healthcare providers, but these cases typically involve influencing doctors' prescribing habits rather than directly corrupting FDA officials.  For instance, in 2016, pharmaceutical executives were charged with a racketeering scheme involving paying kickbacks to doctors to promote an addictive opioid.

 

So, I'm wondering whether any of this is going to stop with the new administration?  Obama didn't care about the kickbacks.  Biden didn't care, either. 

Will Trump, et al. care?  

Time will tell.  

 

In the meantime, what can regular folks do against big pharma and FDA corruption?  

 

Well, we can advocate for legislative reforms, such as increased transparency in funding for researchers and advocacy groups, and reforms to the FDA's fee system that increases industry influence. 

 

We can supporting independent journalism that investigates misconduct, reporting potential conflicts of interest.

 

We can join or support non-profit organizations that work to promote patient safety and advocate for stricter regulations.

 

It's not a lot but at least it's something and sometimes, it's the little things that bring down the mountain.